Mastering IEC 62304 for Medical Device Software Compliance
You are under pressure. Regulatory audits are looming, software traceability is a mess, and your product’s market access hinges on getting IEC 62304 right-fast. One misstep in software lifecycle documentation can delay your submission for months, cost hundreds of thousands in redesigns, or worse-trigger a regulatory rejection that stalls your entire pipeline. The standards are complex, guidance is scattered, and most training gives you theory with zero real-world application. This isn’t just about checking a compliance box. It’s about owning confidence in your software development process so you can present to auditors, stakeholders, and regulators with zero hesitation. Mastering IEC 62304 for Medical Device Software Compliance is the definitive blueprint that transforms confusion into clarity, turning fragmented practices into a robust, auditable, and repeatable framework-so you can take any software-driven medical device from concept to clearance with structured, defensible rigor. A Senior Software Validation Engineer at a Class III device manufacturer told us: “After four failed internal audits due to inadequate software design records, I applied the templates and workflow here. Our next FDA audit passed with zero findings. This course paid for itself 50 times over.” Going from uncertain and reactive to proactive and prepared is no longer a luxury. It’s your competitive edge. Here’s how this course is structured to help you get there.Course Format & Delivery Details Self-Paced Learning with Immediate Online Access
This course is designed for professionals who need flexibility without compromise. You gain on-demand access to all materials from day one, allowing you to progress at your own pace, on your schedule, without fixed start dates or time commitments. Whether you’re fitting this into evenings or accelerating through weekends, the path is yours to control. Fast, Practical Results with Real-World Application
Most learners complete the core curriculum in 12 to 18 hours and implement critical IEC 62304 workflows within the first week. You’ll walk away with actionable artefacts-including software development plans, risk traceability matrices, and verification protocols-that integrate directly into your current projects. Lifetime Access and Ongoing Updates Included
Your investment includes lifetime access to the full course content. As regulatory expectations evolve and new interpretations emerge, you’ll receive all updates automatically at no additional cost. This is not a static resource-it grows with the standard, so your expertise stays current for years. 24/7 Global Access – Mobile-Friendly & Secure
Access the course anytime, anywhere, from any device. Whether you're on-site at a manufacturing facility, traveling between global offices, or working remotely, the platform is fully optimized for desktop, tablet, and mobile-ensuring seamless learning without interruptions. Dedicated Instructor Support and Expert Guidance
You are not navigating this alone. Throughout your journey, you’ll have direct access to experienced IEC 62304 practitioners with decades of real-world compliance experience across Class I, II, and III devices. Submit questions, receive detailed feedback, and clarify complex scenarios with confidence. Receive a Globally Recognised Certificate of Completion
Upon finishing the course, you’ll earn a Certificate of Completion issued by The Art of Service-a credential respected across regulated industries and cited in job applications, LinkedIn profiles, and internal promotions. This is not a participation trophy. It’s proof you’ve mastered the critical nuances of software lifecycle compliance in a high-stakes environment. Transparent, One-Time Pricing – No Hidden Fees
The price you see is the price you pay-no subscriptions, no renewal traps, no surprise charges. Everything you need is included upfront. We accept all major payment methods: Visa, Mastercard, and PayPal. Zero-Risk Enrollment: 30-Day Satisfied-or-Refunded Guarantee
We eliminate your risk with a full 30-day money-back guarantee. If you complete the first three modules and don’t feel a dramatic increase in clarity, confidence, and practical control over IEC 62304 requirements, simply request a refund. No questions, no hassle. Instant Confirmation with Streamlined Access Delivery
After enrollment, you’ll receive an email confirmation within minutes. Your access credentials and login details will follow separately once your course materials are finalized and ready-ensuring a smooth, secure onboarding experience. This Works Even If…
You’ve read the standard but can’t interpret how it applies to agile development. Or your team struggles with traceability between software requirements and verification results. Or you’re new to medical devices and overwhelmed by the regulatory language. This course bridges the gap between theory and practice, written for real engineers, QA leads, and compliance officers working in dynamic product environments. With built-in templates, annotated examples from actual submissions, and direct mappings to FDA and EU MDR expectations, this is the practical guide the official documentation won’t give you. Your success is not left to chance. The framework is proven. The tools are battle-tested. And the risk is entirely on us.
Module 1: Foundations of IEC 62304 and Regulatory Context - Understanding the scope and applicability of IEC 62304 for software in medical devices
- Distinguishing between standalone software and embedded software systems
- Overview of global regulatory frameworks linked to IEC 62304
- Mapping IEC 62304 to FDA Quality System Regulation and EU MDR requirements
- Interpreting software classification according to safety risk categorisation
- Differentiating between Class A, Class B, and Class C software systems
- Understanding the role of software in a quality management system
- Identifying when software requires IEC 62304 compliance
- Overview of the software lifecycle model defined in IEC 62304
- Explaining the relationship between risk management and software development
- Integrating ISO 14971 with IEC 62304 workflows
- Understanding software safety classification decision trees
- Overview of relevant harmonised standards and technical reports
- Introduction to software item versus software system definitions
- Recognising software configuration items and version control needs
- Interpreting clause-by-clause structure of IEC 62304
- Overview of compliance evidence required for regulatory audits
- Defining key terminology used throughout the standard
- Understanding audit expectations for software documentation
- Setting realistic implementation goals based on device class
Module 2: Software Development Process and Lifecycle Planning - Creating a comprehensive software development plan (SDP)
- Defining software development methodologies: waterfall, agile, hybrid
- Aligning software lifecycle phases with organisational workflows
- Establishing software development environment controls
- Defining roles and responsibilities within the software team
- Documenting software development standards and coding conventions
- Designing software development phase entry and exit criteria
- Creating software development schedule and milestone tracking
- Integrating user needs into software requirements
- Defining high-level software architecture principles
- Establishing software design constraints and performance criteria
- Developing software verification and validation strategies early
- Incorporating risk-based approaches into planning documents
- Using templates for repeatable SDP creation
- Aligning SDP with project management tools and Gantt charts
- Managing change control within software development planning
- Recording technical and regulatory assumptions in the SDP
- Defining acceptance criteria for software deliverables
- Managing subcontractor and third-party software development
- Ensuring SDP compliance with internal audit expectations
Module 3: Software Requirements Specification and Traceability - Deriving software requirements from system requirements
- Writing clear, testable, and verifiable software requirements
- Differentiating between functional and non-functional requirements
- Using requirement attributes: ID, version, source, status, priority
- Building a software requirements specification (SRS) document
- Applying best practices for requirement phrasing and clarity
- Ensuring requirements alignment with clinical needs and use cases
- Traceability from user needs to software requirements
- Creating and maintaining a requirements traceability matrix (RTM)
- Linking software requirements to risk analysis outputs
- Mapping software requirements to verification and validation plans
- Managing requirement volatility and change impact analysis
- Using tool-based vs. spreadsheet-based traceability methods
- Ensuring bidirectional traceability throughout the lifecycle
- Documenting requirement rationale and implementation notes
- Handling conflicting or ambiguous requirements
- Validating completeness and consistency of SRS
- Conducting SRS review and approval workflows
- Avoiding common pitfalls in requirement specification
- Using real-world examples from cleared devices
Module 4: Software Architecture and High-Level Design - Defining software architectural design principles
- Creating modular, maintainable, and scalable software structures
- Representing architecture using block diagrams and UML
- Documenting software components and interfaces
- Specifying internal and external communication protocols
- Designing for fault tolerance and safety-critical behaviour
- Allocating software safety requirements to modules
- Defining data flow and control flow within the system
- Establishing software design constraints and dependencies
- Using design patterns relevant to medical device software
- Ensuring separation of concerns in high-level design
- Handling real-time processing and timing constraints
- Designing for updateability, serviceability, and diagnostics
- Documenting software architecture rationale and trade-offs
- Reviewing and approving architecture deliverables
- Mapping architecture to software requirements
- Using threat modelling to inform secure design
- Incorporating cybersecurity considerations in design
- Ensuring design supports verification and validation
- Creating reusable architectural templates
Module 5: Software Detailed Design and Implementation - Translating high-level design into detailed design specifications
- Creating detailed module specifications with interfaces
- Specifying algorithms, state machines, and data structures
- Using pseudocode and flowcharts for algorithm clarity
- Documenting error handling and exception management
- Defining memory and resource management strategies
- Implementing coding standards and style guides
- Selecting programming languages appropriate for medical use
- Managing software reuse: legacy, COTS, open source
- Documenting justification for reused software components
- Incorporating static analysis and code quality tools
- Developing build and compilation processes
- Version control best practices for source code management
- Branching and merging strategies for team development
- Ensuring traceability from detailed design to code
- Performing peer code reviews and inspections
- Using automated linting and formatting tools
- Managing software configuration items (SCIs)
- Documenting software builds and release versions
- Preparing for software integration testing
Module 6: Software Unit and Integration Testing - Developing unit test plans and procedures
- Writing unit tests using white-box and black-box techniques
- Measuring code coverage: statement, branch, condition
- Setting coverage targets based on software safety class
- Using automated unit testing frameworks
- Documenting unit test results and deviations
- Establishing pass/fail criteria for unit testing
- Reporting and managing unit test defects
- Retesting and regression testing workflows
- Integrating unit testing into continuous integration
- Defining integration testing strategy and scope
- Creating integration test plans and procedures
- Testing component interactions and interface compatibility
- Verifying data and control flow between modules
- Handling timing and race conditions in integrated systems
- Simulating hardware and external system interfaces
- Using test harnesses and stubs for integration testing
- Documenting integration test evidence
- Ensuring traceability from integration tests to requirements
- Managing test environment configuration and controls
Module 7: Software Verification and Validation - Differentiating verification from validation in practice
- Creating a software verification plan (SVP)
- Writing software verification and validation protocols
- Developing test cases from software requirements
- Designing black-box testing for functional validation
- Incorporating risk-based test case prioritisation
- Defining test environments and setup procedures
- Using simulated and actual hardware for testing
- Ensuring independence of test execution and review
- Executing and documenting verification test runs
- Confirming traceability from test cases to requirements
- Handling test deviations and failures systematically
- Managing change impact on existing test cases
- Performing regression testing after modifications
- Summarising test results in verification reports
- Capturing evidence for regulatory submissions
- Aligning test protocols with FDA 21 CFR Part 11
- Validating usability and human factors integration
- Testing for software performance and resource usage
- Ensuring alignment with software design outputs
Module 8: Software Risk Management Integration - Integrating ISO 14971 risk management activities with IEC 62304
- Linking software hazards to software requirements
- Documenting software-related hazard scenarios
- Assessing severity and probability of software failures
- Implementing risk control measures in software design
- Validating effectiveness of software risk controls
- Using fault tree analysis (FTA) for software hazards
- Applying failure mode and effects analysis (FMEA) to software
- Creating software risk traceability matrices
- Ensuring risk documentation is lifecycle-controlled
- Reviewing risk documentation at phase gates
- Updating risk analysis after software changes
- Linking risk artifacts to verification activities
- Documenting residual risk acceptability
- Supporting risk-benefit analysis submissions
- Handling cybersecurity-related software risks
- Using automated tools to support risk documentation
- Training teams on risk-aware software development
- Preparing risk files for notified body audits
- Aligning risk strategy with international regulatory expectations
Module 9: Software Configuration Management - Establishing software configuration management (SCM) processes
- Defining software configuration items (SCIs) and baselines
- Creating software configuration management plans
- Using version control systems: Git, SVN, Perforce
- Implementing branching, tagging, and release workflows
- Documenting software build and release procedures
- Ensuring reproducible builds and traceable versions
- Managing access controls and permissions
- Conducting software configuration audits
- Recording changes and justifications in change logs
- Integrating SCM with change control boards
- Handling configuration drift and unauthorised changes
- Ensuring configuration management in agile environments
- Automating builds and deployment pipelines
- Validating configuration management tools
- Linking configuration items to requirements and tests
- Managing third-party and open-source software versions
- Documenting software metadata and dependencies
- Ensuring SCM compliance with regulatory inspectors
- Preparing for configuration audits during submissions
Module 10: Software Problem Resolution and Maintenance - Defining software problem resolution processes
- Classifying software issues: bug, enhancement, vulnerability
- Establishing software problem reporting workflows
- Investigating root causes of software anomalies
- Using root cause analysis techniques: 5 Whys, Ishikawa
- Linking problem reports to risk management outputs
- Determining need for field safety corrective actions (FSCA)
- Assessing software change impact on compliance
- Managing software patches, updates, and versioning
- Validating fixes before deployment
- Documenting software maintenance records
- Ensuring timely communication of software issues
- Integrating customer feedback into improvement loops
- Tracking software problem resolution metrics
- Conducting post-deployment surveillance
- Updating design history files with maintenance records
- Ensuring post-market changes comply with IEC 62304
- Managing software updates during product lifecycle
- Aligning maintenance activities with regulatory reporting
- Preparing for software-related incident investigations
Module 11: Software Lifecycle Management and Documentation - Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Understanding the scope and applicability of IEC 62304 for software in medical devices
- Distinguishing between standalone software and embedded software systems
- Overview of global regulatory frameworks linked to IEC 62304
- Mapping IEC 62304 to FDA Quality System Regulation and EU MDR requirements
- Interpreting software classification according to safety risk categorisation
- Differentiating between Class A, Class B, and Class C software systems
- Understanding the role of software in a quality management system
- Identifying when software requires IEC 62304 compliance
- Overview of the software lifecycle model defined in IEC 62304
- Explaining the relationship between risk management and software development
- Integrating ISO 14971 with IEC 62304 workflows
- Understanding software safety classification decision trees
- Overview of relevant harmonised standards and technical reports
- Introduction to software item versus software system definitions
- Recognising software configuration items and version control needs
- Interpreting clause-by-clause structure of IEC 62304
- Overview of compliance evidence required for regulatory audits
- Defining key terminology used throughout the standard
- Understanding audit expectations for software documentation
- Setting realistic implementation goals based on device class
Module 2: Software Development Process and Lifecycle Planning - Creating a comprehensive software development plan (SDP)
- Defining software development methodologies: waterfall, agile, hybrid
- Aligning software lifecycle phases with organisational workflows
- Establishing software development environment controls
- Defining roles and responsibilities within the software team
- Documenting software development standards and coding conventions
- Designing software development phase entry and exit criteria
- Creating software development schedule and milestone tracking
- Integrating user needs into software requirements
- Defining high-level software architecture principles
- Establishing software design constraints and performance criteria
- Developing software verification and validation strategies early
- Incorporating risk-based approaches into planning documents
- Using templates for repeatable SDP creation
- Aligning SDP with project management tools and Gantt charts
- Managing change control within software development planning
- Recording technical and regulatory assumptions in the SDP
- Defining acceptance criteria for software deliverables
- Managing subcontractor and third-party software development
- Ensuring SDP compliance with internal audit expectations
Module 3: Software Requirements Specification and Traceability - Deriving software requirements from system requirements
- Writing clear, testable, and verifiable software requirements
- Differentiating between functional and non-functional requirements
- Using requirement attributes: ID, version, source, status, priority
- Building a software requirements specification (SRS) document
- Applying best practices for requirement phrasing and clarity
- Ensuring requirements alignment with clinical needs and use cases
- Traceability from user needs to software requirements
- Creating and maintaining a requirements traceability matrix (RTM)
- Linking software requirements to risk analysis outputs
- Mapping software requirements to verification and validation plans
- Managing requirement volatility and change impact analysis
- Using tool-based vs. spreadsheet-based traceability methods
- Ensuring bidirectional traceability throughout the lifecycle
- Documenting requirement rationale and implementation notes
- Handling conflicting or ambiguous requirements
- Validating completeness and consistency of SRS
- Conducting SRS review and approval workflows
- Avoiding common pitfalls in requirement specification
- Using real-world examples from cleared devices
Module 4: Software Architecture and High-Level Design - Defining software architectural design principles
- Creating modular, maintainable, and scalable software structures
- Representing architecture using block diagrams and UML
- Documenting software components and interfaces
- Specifying internal and external communication protocols
- Designing for fault tolerance and safety-critical behaviour
- Allocating software safety requirements to modules
- Defining data flow and control flow within the system
- Establishing software design constraints and dependencies
- Using design patterns relevant to medical device software
- Ensuring separation of concerns in high-level design
- Handling real-time processing and timing constraints
- Designing for updateability, serviceability, and diagnostics
- Documenting software architecture rationale and trade-offs
- Reviewing and approving architecture deliverables
- Mapping architecture to software requirements
- Using threat modelling to inform secure design
- Incorporating cybersecurity considerations in design
- Ensuring design supports verification and validation
- Creating reusable architectural templates
Module 5: Software Detailed Design and Implementation - Translating high-level design into detailed design specifications
- Creating detailed module specifications with interfaces
- Specifying algorithms, state machines, and data structures
- Using pseudocode and flowcharts for algorithm clarity
- Documenting error handling and exception management
- Defining memory and resource management strategies
- Implementing coding standards and style guides
- Selecting programming languages appropriate for medical use
- Managing software reuse: legacy, COTS, open source
- Documenting justification for reused software components
- Incorporating static analysis and code quality tools
- Developing build and compilation processes
- Version control best practices for source code management
- Branching and merging strategies for team development
- Ensuring traceability from detailed design to code
- Performing peer code reviews and inspections
- Using automated linting and formatting tools
- Managing software configuration items (SCIs)
- Documenting software builds and release versions
- Preparing for software integration testing
Module 6: Software Unit and Integration Testing - Developing unit test plans and procedures
- Writing unit tests using white-box and black-box techniques
- Measuring code coverage: statement, branch, condition
- Setting coverage targets based on software safety class
- Using automated unit testing frameworks
- Documenting unit test results and deviations
- Establishing pass/fail criteria for unit testing
- Reporting and managing unit test defects
- Retesting and regression testing workflows
- Integrating unit testing into continuous integration
- Defining integration testing strategy and scope
- Creating integration test plans and procedures
- Testing component interactions and interface compatibility
- Verifying data and control flow between modules
- Handling timing and race conditions in integrated systems
- Simulating hardware and external system interfaces
- Using test harnesses and stubs for integration testing
- Documenting integration test evidence
- Ensuring traceability from integration tests to requirements
- Managing test environment configuration and controls
Module 7: Software Verification and Validation - Differentiating verification from validation in practice
- Creating a software verification plan (SVP)
- Writing software verification and validation protocols
- Developing test cases from software requirements
- Designing black-box testing for functional validation
- Incorporating risk-based test case prioritisation
- Defining test environments and setup procedures
- Using simulated and actual hardware for testing
- Ensuring independence of test execution and review
- Executing and documenting verification test runs
- Confirming traceability from test cases to requirements
- Handling test deviations and failures systematically
- Managing change impact on existing test cases
- Performing regression testing after modifications
- Summarising test results in verification reports
- Capturing evidence for regulatory submissions
- Aligning test protocols with FDA 21 CFR Part 11
- Validating usability and human factors integration
- Testing for software performance and resource usage
- Ensuring alignment with software design outputs
Module 8: Software Risk Management Integration - Integrating ISO 14971 risk management activities with IEC 62304
- Linking software hazards to software requirements
- Documenting software-related hazard scenarios
- Assessing severity and probability of software failures
- Implementing risk control measures in software design
- Validating effectiveness of software risk controls
- Using fault tree analysis (FTA) for software hazards
- Applying failure mode and effects analysis (FMEA) to software
- Creating software risk traceability matrices
- Ensuring risk documentation is lifecycle-controlled
- Reviewing risk documentation at phase gates
- Updating risk analysis after software changes
- Linking risk artifacts to verification activities
- Documenting residual risk acceptability
- Supporting risk-benefit analysis submissions
- Handling cybersecurity-related software risks
- Using automated tools to support risk documentation
- Training teams on risk-aware software development
- Preparing risk files for notified body audits
- Aligning risk strategy with international regulatory expectations
Module 9: Software Configuration Management - Establishing software configuration management (SCM) processes
- Defining software configuration items (SCIs) and baselines
- Creating software configuration management plans
- Using version control systems: Git, SVN, Perforce
- Implementing branching, tagging, and release workflows
- Documenting software build and release procedures
- Ensuring reproducible builds and traceable versions
- Managing access controls and permissions
- Conducting software configuration audits
- Recording changes and justifications in change logs
- Integrating SCM with change control boards
- Handling configuration drift and unauthorised changes
- Ensuring configuration management in agile environments
- Automating builds and deployment pipelines
- Validating configuration management tools
- Linking configuration items to requirements and tests
- Managing third-party and open-source software versions
- Documenting software metadata and dependencies
- Ensuring SCM compliance with regulatory inspectors
- Preparing for configuration audits during submissions
Module 10: Software Problem Resolution and Maintenance - Defining software problem resolution processes
- Classifying software issues: bug, enhancement, vulnerability
- Establishing software problem reporting workflows
- Investigating root causes of software anomalies
- Using root cause analysis techniques: 5 Whys, Ishikawa
- Linking problem reports to risk management outputs
- Determining need for field safety corrective actions (FSCA)
- Assessing software change impact on compliance
- Managing software patches, updates, and versioning
- Validating fixes before deployment
- Documenting software maintenance records
- Ensuring timely communication of software issues
- Integrating customer feedback into improvement loops
- Tracking software problem resolution metrics
- Conducting post-deployment surveillance
- Updating design history files with maintenance records
- Ensuring post-market changes comply with IEC 62304
- Managing software updates during product lifecycle
- Aligning maintenance activities with regulatory reporting
- Preparing for software-related incident investigations
Module 11: Software Lifecycle Management and Documentation - Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Deriving software requirements from system requirements
- Writing clear, testable, and verifiable software requirements
- Differentiating between functional and non-functional requirements
- Using requirement attributes: ID, version, source, status, priority
- Building a software requirements specification (SRS) document
- Applying best practices for requirement phrasing and clarity
- Ensuring requirements alignment with clinical needs and use cases
- Traceability from user needs to software requirements
- Creating and maintaining a requirements traceability matrix (RTM)
- Linking software requirements to risk analysis outputs
- Mapping software requirements to verification and validation plans
- Managing requirement volatility and change impact analysis
- Using tool-based vs. spreadsheet-based traceability methods
- Ensuring bidirectional traceability throughout the lifecycle
- Documenting requirement rationale and implementation notes
- Handling conflicting or ambiguous requirements
- Validating completeness and consistency of SRS
- Conducting SRS review and approval workflows
- Avoiding common pitfalls in requirement specification
- Using real-world examples from cleared devices
Module 4: Software Architecture and High-Level Design - Defining software architectural design principles
- Creating modular, maintainable, and scalable software structures
- Representing architecture using block diagrams and UML
- Documenting software components and interfaces
- Specifying internal and external communication protocols
- Designing for fault tolerance and safety-critical behaviour
- Allocating software safety requirements to modules
- Defining data flow and control flow within the system
- Establishing software design constraints and dependencies
- Using design patterns relevant to medical device software
- Ensuring separation of concerns in high-level design
- Handling real-time processing and timing constraints
- Designing for updateability, serviceability, and diagnostics
- Documenting software architecture rationale and trade-offs
- Reviewing and approving architecture deliverables
- Mapping architecture to software requirements
- Using threat modelling to inform secure design
- Incorporating cybersecurity considerations in design
- Ensuring design supports verification and validation
- Creating reusable architectural templates
Module 5: Software Detailed Design and Implementation - Translating high-level design into detailed design specifications
- Creating detailed module specifications with interfaces
- Specifying algorithms, state machines, and data structures
- Using pseudocode and flowcharts for algorithm clarity
- Documenting error handling and exception management
- Defining memory and resource management strategies
- Implementing coding standards and style guides
- Selecting programming languages appropriate for medical use
- Managing software reuse: legacy, COTS, open source
- Documenting justification for reused software components
- Incorporating static analysis and code quality tools
- Developing build and compilation processes
- Version control best practices for source code management
- Branching and merging strategies for team development
- Ensuring traceability from detailed design to code
- Performing peer code reviews and inspections
- Using automated linting and formatting tools
- Managing software configuration items (SCIs)
- Documenting software builds and release versions
- Preparing for software integration testing
Module 6: Software Unit and Integration Testing - Developing unit test plans and procedures
- Writing unit tests using white-box and black-box techniques
- Measuring code coverage: statement, branch, condition
- Setting coverage targets based on software safety class
- Using automated unit testing frameworks
- Documenting unit test results and deviations
- Establishing pass/fail criteria for unit testing
- Reporting and managing unit test defects
- Retesting and regression testing workflows
- Integrating unit testing into continuous integration
- Defining integration testing strategy and scope
- Creating integration test plans and procedures
- Testing component interactions and interface compatibility
- Verifying data and control flow between modules
- Handling timing and race conditions in integrated systems
- Simulating hardware and external system interfaces
- Using test harnesses and stubs for integration testing
- Documenting integration test evidence
- Ensuring traceability from integration tests to requirements
- Managing test environment configuration and controls
Module 7: Software Verification and Validation - Differentiating verification from validation in practice
- Creating a software verification plan (SVP)
- Writing software verification and validation protocols
- Developing test cases from software requirements
- Designing black-box testing for functional validation
- Incorporating risk-based test case prioritisation
- Defining test environments and setup procedures
- Using simulated and actual hardware for testing
- Ensuring independence of test execution and review
- Executing and documenting verification test runs
- Confirming traceability from test cases to requirements
- Handling test deviations and failures systematically
- Managing change impact on existing test cases
- Performing regression testing after modifications
- Summarising test results in verification reports
- Capturing evidence for regulatory submissions
- Aligning test protocols with FDA 21 CFR Part 11
- Validating usability and human factors integration
- Testing for software performance and resource usage
- Ensuring alignment with software design outputs
Module 8: Software Risk Management Integration - Integrating ISO 14971 risk management activities with IEC 62304
- Linking software hazards to software requirements
- Documenting software-related hazard scenarios
- Assessing severity and probability of software failures
- Implementing risk control measures in software design
- Validating effectiveness of software risk controls
- Using fault tree analysis (FTA) for software hazards
- Applying failure mode and effects analysis (FMEA) to software
- Creating software risk traceability matrices
- Ensuring risk documentation is lifecycle-controlled
- Reviewing risk documentation at phase gates
- Updating risk analysis after software changes
- Linking risk artifacts to verification activities
- Documenting residual risk acceptability
- Supporting risk-benefit analysis submissions
- Handling cybersecurity-related software risks
- Using automated tools to support risk documentation
- Training teams on risk-aware software development
- Preparing risk files for notified body audits
- Aligning risk strategy with international regulatory expectations
Module 9: Software Configuration Management - Establishing software configuration management (SCM) processes
- Defining software configuration items (SCIs) and baselines
- Creating software configuration management plans
- Using version control systems: Git, SVN, Perforce
- Implementing branching, tagging, and release workflows
- Documenting software build and release procedures
- Ensuring reproducible builds and traceable versions
- Managing access controls and permissions
- Conducting software configuration audits
- Recording changes and justifications in change logs
- Integrating SCM with change control boards
- Handling configuration drift and unauthorised changes
- Ensuring configuration management in agile environments
- Automating builds and deployment pipelines
- Validating configuration management tools
- Linking configuration items to requirements and tests
- Managing third-party and open-source software versions
- Documenting software metadata and dependencies
- Ensuring SCM compliance with regulatory inspectors
- Preparing for configuration audits during submissions
Module 10: Software Problem Resolution and Maintenance - Defining software problem resolution processes
- Classifying software issues: bug, enhancement, vulnerability
- Establishing software problem reporting workflows
- Investigating root causes of software anomalies
- Using root cause analysis techniques: 5 Whys, Ishikawa
- Linking problem reports to risk management outputs
- Determining need for field safety corrective actions (FSCA)
- Assessing software change impact on compliance
- Managing software patches, updates, and versioning
- Validating fixes before deployment
- Documenting software maintenance records
- Ensuring timely communication of software issues
- Integrating customer feedback into improvement loops
- Tracking software problem resolution metrics
- Conducting post-deployment surveillance
- Updating design history files with maintenance records
- Ensuring post-market changes comply with IEC 62304
- Managing software updates during product lifecycle
- Aligning maintenance activities with regulatory reporting
- Preparing for software-related incident investigations
Module 11: Software Lifecycle Management and Documentation - Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Translating high-level design into detailed design specifications
- Creating detailed module specifications with interfaces
- Specifying algorithms, state machines, and data structures
- Using pseudocode and flowcharts for algorithm clarity
- Documenting error handling and exception management
- Defining memory and resource management strategies
- Implementing coding standards and style guides
- Selecting programming languages appropriate for medical use
- Managing software reuse: legacy, COTS, open source
- Documenting justification for reused software components
- Incorporating static analysis and code quality tools
- Developing build and compilation processes
- Version control best practices for source code management
- Branching and merging strategies for team development
- Ensuring traceability from detailed design to code
- Performing peer code reviews and inspections
- Using automated linting and formatting tools
- Managing software configuration items (SCIs)
- Documenting software builds and release versions
- Preparing for software integration testing
Module 6: Software Unit and Integration Testing - Developing unit test plans and procedures
- Writing unit tests using white-box and black-box techniques
- Measuring code coverage: statement, branch, condition
- Setting coverage targets based on software safety class
- Using automated unit testing frameworks
- Documenting unit test results and deviations
- Establishing pass/fail criteria for unit testing
- Reporting and managing unit test defects
- Retesting and regression testing workflows
- Integrating unit testing into continuous integration
- Defining integration testing strategy and scope
- Creating integration test plans and procedures
- Testing component interactions and interface compatibility
- Verifying data and control flow between modules
- Handling timing and race conditions in integrated systems
- Simulating hardware and external system interfaces
- Using test harnesses and stubs for integration testing
- Documenting integration test evidence
- Ensuring traceability from integration tests to requirements
- Managing test environment configuration and controls
Module 7: Software Verification and Validation - Differentiating verification from validation in practice
- Creating a software verification plan (SVP)
- Writing software verification and validation protocols
- Developing test cases from software requirements
- Designing black-box testing for functional validation
- Incorporating risk-based test case prioritisation
- Defining test environments and setup procedures
- Using simulated and actual hardware for testing
- Ensuring independence of test execution and review
- Executing and documenting verification test runs
- Confirming traceability from test cases to requirements
- Handling test deviations and failures systematically
- Managing change impact on existing test cases
- Performing regression testing after modifications
- Summarising test results in verification reports
- Capturing evidence for regulatory submissions
- Aligning test protocols with FDA 21 CFR Part 11
- Validating usability and human factors integration
- Testing for software performance and resource usage
- Ensuring alignment with software design outputs
Module 8: Software Risk Management Integration - Integrating ISO 14971 risk management activities with IEC 62304
- Linking software hazards to software requirements
- Documenting software-related hazard scenarios
- Assessing severity and probability of software failures
- Implementing risk control measures in software design
- Validating effectiveness of software risk controls
- Using fault tree analysis (FTA) for software hazards
- Applying failure mode and effects analysis (FMEA) to software
- Creating software risk traceability matrices
- Ensuring risk documentation is lifecycle-controlled
- Reviewing risk documentation at phase gates
- Updating risk analysis after software changes
- Linking risk artifacts to verification activities
- Documenting residual risk acceptability
- Supporting risk-benefit analysis submissions
- Handling cybersecurity-related software risks
- Using automated tools to support risk documentation
- Training teams on risk-aware software development
- Preparing risk files for notified body audits
- Aligning risk strategy with international regulatory expectations
Module 9: Software Configuration Management - Establishing software configuration management (SCM) processes
- Defining software configuration items (SCIs) and baselines
- Creating software configuration management plans
- Using version control systems: Git, SVN, Perforce
- Implementing branching, tagging, and release workflows
- Documenting software build and release procedures
- Ensuring reproducible builds and traceable versions
- Managing access controls and permissions
- Conducting software configuration audits
- Recording changes and justifications in change logs
- Integrating SCM with change control boards
- Handling configuration drift and unauthorised changes
- Ensuring configuration management in agile environments
- Automating builds and deployment pipelines
- Validating configuration management tools
- Linking configuration items to requirements and tests
- Managing third-party and open-source software versions
- Documenting software metadata and dependencies
- Ensuring SCM compliance with regulatory inspectors
- Preparing for configuration audits during submissions
Module 10: Software Problem Resolution and Maintenance - Defining software problem resolution processes
- Classifying software issues: bug, enhancement, vulnerability
- Establishing software problem reporting workflows
- Investigating root causes of software anomalies
- Using root cause analysis techniques: 5 Whys, Ishikawa
- Linking problem reports to risk management outputs
- Determining need for field safety corrective actions (FSCA)
- Assessing software change impact on compliance
- Managing software patches, updates, and versioning
- Validating fixes before deployment
- Documenting software maintenance records
- Ensuring timely communication of software issues
- Integrating customer feedback into improvement loops
- Tracking software problem resolution metrics
- Conducting post-deployment surveillance
- Updating design history files with maintenance records
- Ensuring post-market changes comply with IEC 62304
- Managing software updates during product lifecycle
- Aligning maintenance activities with regulatory reporting
- Preparing for software-related incident investigations
Module 11: Software Lifecycle Management and Documentation - Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Differentiating verification from validation in practice
- Creating a software verification plan (SVP)
- Writing software verification and validation protocols
- Developing test cases from software requirements
- Designing black-box testing for functional validation
- Incorporating risk-based test case prioritisation
- Defining test environments and setup procedures
- Using simulated and actual hardware for testing
- Ensuring independence of test execution and review
- Executing and documenting verification test runs
- Confirming traceability from test cases to requirements
- Handling test deviations and failures systematically
- Managing change impact on existing test cases
- Performing regression testing after modifications
- Summarising test results in verification reports
- Capturing evidence for regulatory submissions
- Aligning test protocols with FDA 21 CFR Part 11
- Validating usability and human factors integration
- Testing for software performance and resource usage
- Ensuring alignment with software design outputs
Module 8: Software Risk Management Integration - Integrating ISO 14971 risk management activities with IEC 62304
- Linking software hazards to software requirements
- Documenting software-related hazard scenarios
- Assessing severity and probability of software failures
- Implementing risk control measures in software design
- Validating effectiveness of software risk controls
- Using fault tree analysis (FTA) for software hazards
- Applying failure mode and effects analysis (FMEA) to software
- Creating software risk traceability matrices
- Ensuring risk documentation is lifecycle-controlled
- Reviewing risk documentation at phase gates
- Updating risk analysis after software changes
- Linking risk artifacts to verification activities
- Documenting residual risk acceptability
- Supporting risk-benefit analysis submissions
- Handling cybersecurity-related software risks
- Using automated tools to support risk documentation
- Training teams on risk-aware software development
- Preparing risk files for notified body audits
- Aligning risk strategy with international regulatory expectations
Module 9: Software Configuration Management - Establishing software configuration management (SCM) processes
- Defining software configuration items (SCIs) and baselines
- Creating software configuration management plans
- Using version control systems: Git, SVN, Perforce
- Implementing branching, tagging, and release workflows
- Documenting software build and release procedures
- Ensuring reproducible builds and traceable versions
- Managing access controls and permissions
- Conducting software configuration audits
- Recording changes and justifications in change logs
- Integrating SCM with change control boards
- Handling configuration drift and unauthorised changes
- Ensuring configuration management in agile environments
- Automating builds and deployment pipelines
- Validating configuration management tools
- Linking configuration items to requirements and tests
- Managing third-party and open-source software versions
- Documenting software metadata and dependencies
- Ensuring SCM compliance with regulatory inspectors
- Preparing for configuration audits during submissions
Module 10: Software Problem Resolution and Maintenance - Defining software problem resolution processes
- Classifying software issues: bug, enhancement, vulnerability
- Establishing software problem reporting workflows
- Investigating root causes of software anomalies
- Using root cause analysis techniques: 5 Whys, Ishikawa
- Linking problem reports to risk management outputs
- Determining need for field safety corrective actions (FSCA)
- Assessing software change impact on compliance
- Managing software patches, updates, and versioning
- Validating fixes before deployment
- Documenting software maintenance records
- Ensuring timely communication of software issues
- Integrating customer feedback into improvement loops
- Tracking software problem resolution metrics
- Conducting post-deployment surveillance
- Updating design history files with maintenance records
- Ensuring post-market changes comply with IEC 62304
- Managing software updates during product lifecycle
- Aligning maintenance activities with regulatory reporting
- Preparing for software-related incident investigations
Module 11: Software Lifecycle Management and Documentation - Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Establishing software configuration management (SCM) processes
- Defining software configuration items (SCIs) and baselines
- Creating software configuration management plans
- Using version control systems: Git, SVN, Perforce
- Implementing branching, tagging, and release workflows
- Documenting software build and release procedures
- Ensuring reproducible builds and traceable versions
- Managing access controls and permissions
- Conducting software configuration audits
- Recording changes and justifications in change logs
- Integrating SCM with change control boards
- Handling configuration drift and unauthorised changes
- Ensuring configuration management in agile environments
- Automating builds and deployment pipelines
- Validating configuration management tools
- Linking configuration items to requirements and tests
- Managing third-party and open-source software versions
- Documenting software metadata and dependencies
- Ensuring SCM compliance with regulatory inspectors
- Preparing for configuration audits during submissions
Module 10: Software Problem Resolution and Maintenance - Defining software problem resolution processes
- Classifying software issues: bug, enhancement, vulnerability
- Establishing software problem reporting workflows
- Investigating root causes of software anomalies
- Using root cause analysis techniques: 5 Whys, Ishikawa
- Linking problem reports to risk management outputs
- Determining need for field safety corrective actions (FSCA)
- Assessing software change impact on compliance
- Managing software patches, updates, and versioning
- Validating fixes before deployment
- Documenting software maintenance records
- Ensuring timely communication of software issues
- Integrating customer feedback into improvement loops
- Tracking software problem resolution metrics
- Conducting post-deployment surveillance
- Updating design history files with maintenance records
- Ensuring post-market changes comply with IEC 62304
- Managing software updates during product lifecycle
- Aligning maintenance activities with regulatory reporting
- Preparing for software-related incident investigations
Module 11: Software Lifecycle Management and Documentation - Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Mapping IEC 62304 clauses to documentation deliverables
- Creating comprehensive software lifecycle records
- Organising documentation for regulatory audits
- Using document control systems and versioning
- Ensuring document review and approval workflows
- Linking deliverables to phase gate reviews
- Generating software design history file contents
- Integrating documentation with quality management systems
- Standardising templates across software projects
- Ensuring document traceability and completeness
- Archiving records according to retention policies
- Preparing for unannounced regulatory inspections
- Creating summary documentation for auditors
- Using checklist-based document reviews
- Training teams on compliant documentation practices
- Ensuring clarity, accuracy, and consistency in records
- Reducing documentation rework and audit findings
- Mapping documents to FDA and EU MDR expectations
- Using electronic signatures where appropriate
- Ensuring records are accessible and secure
Module 12: Agile and Iterative Development Compliance - Applying IEC 62304 to agile development methodologies
- Aligning sprints with software lifecycle phases
- Ensuring traceability in dynamic backlogs
- Integrating risk management into sprint planning
- Managing requirements in user stories and epics
- Creating rolling software development plans
- Conducting phase gate reviews in agile settings
- Documenting architecture evolution over time
- Ensuring code quality in continuous integration
- Applying verification activities incrementally
- Using agile tools: Jira, Azure DevOps, Trello
- Generating audit trails from agile tools
- Meeting regulatory expectations in fast-moving teams
- Justifying agile use in regulatory submissions
- Training cross-functional teams on compliance
- Balancing speed and rigour in iterative releases
- Handling technical debt in regulated software
- Ensuring management review in agile projects
- Using retrospectives to improve compliance practices
- Documenting decisions in agile meeting records
Module 13: Third-Party and Legacy Software Integration - Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Classifying third-party software: COTS, open source, SDKs
- Assessing vendor compliance with IEC 62304
- Obtaining vendor documentation for audit purposes
- Validating vendor claims and test evidence
- Conducting due diligence on software suppliers
- Managing supplier agreements for regulatory compliance
- Integrating vendor software into internal traceability
- Documenting justification for third-party software use
- Handling software with incomplete or missing records
- Adapting legacy software to current standards
- Re-baselining legacy systems with new documentation
- Assessing software change impact after integration
- Performing gap analysis on legacy code
- Incrementally bringing legacy software into compliance
- Using reverse engineering techniques carefully and ethically
- Documenting software modernisation decisions
- Ensuring cybersecurity of third-party components
- Updating software bill of materials (SBOM)
- Managing open-source license compliance
- Supporting regulatory submissions with legacy evidence
Module 14: Preparing for Audits and Regulatory Submissions - Creating a regulatory-ready software validation package
- Organising documentation for FDA 510(k) submissions
- Preparing software sections for EU MDR technical files
- Compiling evidence for notified body reviews
- Responding to audit findings and deficiency letters
- Simulating mock regulatory audits
- Training teams for auditor interviews
- Highlighting compliance strengths proactively
- Anticipating common inspector questions
- Ensuring consistency across all documents
- Using checklists to verify submission completeness
- Preparing executive summaries for stakeholders
- Aligning software data with clinical evaluation reports
- Supporting software updates in post-market submissions
- Documenting software lifecycle in regulatory narratives
- Using flowcharts and diagrams for clarity
- Creating indices and navigation aids for reviewers
- Ensuring file formats are compatible and accessible
- Demonstrating management oversight and review
- Presenting software compliance as a strategic asset
Module 15: Certification, Career Advancement and Next Steps - Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle
- Reviewing final requirements for Certificate of Completion
- Submitting your completion dossier for evaluation
- Receiving official certification from The Art of Service
- Adding certification to LinkedIn and professional profiles
- Using certification in job applications and promotions
- Becoming a recognised IEC 62304 subject matter expert
- Leading internal compliance initiatives and training
- Mentoring teams on software lifecycle best practices
- Contributing to regulatory strategy and submissions
- Expanding expertise into related standards: IEC 82304, IEC 81001
- Preparing for advanced roles: QA Lead, Software CTO, Regulatory Head
- Building a personal portfolio of compliant artefacts
- Accessing exclusive alumni resources and updates
- Joining a network of medical device compliance professionals
- Participating in continuing education opportunities
- Staying informed on emerging regulatory trends
- Using templates beyond this course in future projects
- Advocating for process improvement in your organisation
- Driving product success through structured software control
- Turning compliance into innovation enabler rather than obstacle