IEC 62304 A Complete Guide
You're under pressure. Regulatory deadlines are tightening, auditors are watching, and your team depends on you to ensure every software development decision meets strict medical device standards. One misstep could delay product launch, trigger non-conformances, or worse-jeopardize patient safety. The IEC 62304 standard isn’t just a checklist. It’s a core competency now. And if you’re not fluent in its structure, lifecycle phases, and classification requirements, you’re operating at risk. You’re not alone. Many professionals in software engineering, quality assurance, and regulatory affairs are expected to deliver compliance without being given the structured knowledge to do so confidently. IEC 62304 A Complete Guide is the definitive solution. This course transforms uncertainty into mastery. It’s designed to take you from confusion to clarity-and fast. In just 40 hours of self-paced learning, you’ll build a board-ready, audit-proof understanding of the entire standard, with actionable frameworks you can apply immediately in your projects. Take Sarah Lim, Principal Software Architect at a Class III medical device startup in Germany. After completing this course, she led her company through a successful pre-market audit where her team’s documentation was praised by notified body assessors for its alignment with IEC 62304 requirements. “This course didn’t just teach me the rules,” she said. “It gave me the confidence to lead development with compliance built in from day one.” This isn’t theoretical fluff. You’ll walk away with a complete internal process guide, traceability templates, and risk classification strategies used by top-tier MedTech firms-all crafted through structured, hands-on learning. You’ll gain not just knowledge, but authority. Here’s how this course is structured to help you get there.Course Format & Delivery Details Designed for Professionals Who Demand Certainty and Results
Every detail of this course has been engineered to eliminate friction, accelerate mastery, and maximise your career ROI. This is not a generic overview. It’s a precision-built learning system trusted by engineers, QA leads, and regulatory specialists across the global medical device industry. Self-Paced. Immediate Online Access. Begin the moment you’re ready. No waiting for cohorts or live sessions. The entire course is available on-demand with no fixed dates, time commitments, or expiry. Most learners complete the full curriculum in 40 hours-and begin applying key concepts within the first 8 hours. Many report immediate improvements in documentation practices, risk assessments, and audit readiness after completing just the first two modules. Lifetime Access & Future Updates Included
Your enrolment includes perpetual access to all course materials. Every update to reflect evolving regulatory expectations, best practices, or new interpretations of IEC 62304 will be delivered to you at no extra cost. This is your living, up-to-date reference system for the lifetime of your career. Engineered for Global, Anytime Learning
- 24/7 access from any country, time zone, or device
- 100% mobile-friendly design-review key concepts during commutes or between meetings
- Progress tracking and checkpoint quizzes ensure you retain and apply what you learn
Expert Guidance Built Into Every Module
You’re not learning in isolation. Each section includes direct guidance from certified medical device auditors and senior software development leads with over 15 years of IEC 62304 implementation experience. You’ll receive clear, role-specific insights-whether you’re a developer, QA manager, or regulatory strategist. Certificate of Completion Issued by The Art of Service
Upon finishing, you’ll earn a verifiable Certificate of Completion from The Art of Service, a globally recognised professional training organisation with over 200,000 certified practitioners. This credential signals your expertise to auditors, regulators, and hiring managers-and is increasingly referenced in job requirements for MedTech roles. Transparent, Upfront Pricing. No Hidden Fees.
One simple price covers everything. No upsells, no subscriptions, no surprise charges. What you see is exactly what you get. We accept all major payment methods including Visa, Mastercard, and PayPal-securely processed with bank-level encryption. Satisfied or Refunded: 30-Day Risk-Free Guarantee
We guarantee your satisfaction. If you complete the first three modules and feel the course doesn’t meet your expectations, simply contact support for a full refund. No questions asked. This is our promise to eliminate your risk. Enrolment Confirmation & Access Process
After enrolling, you’ll receive a confirmation email. Your official access details and login information will be sent separately once your course materials are fully prepared. This ensures a smooth, high-integrity onboarding experience for every learner. This Works Even If...
- You’ve never led a full software lifecycle in a regulated environment
- You’re transitioning from general software engineering to medical devices
- You’re under active audit preparation and need clarity fast
- You’re non-native in technical documentation but must produce audit-ready artefacts
- You’ve read the standard but still don’t know how to implement it correctly
This course was built for real-world complexity. We don’t assume prior mastery. We ensure it.
Module 1: Foundations of IEC 62304 – Understanding the Standard - What is IEC 62304 and why it matters in medical device software
- Overview of global regulatory context: FDA, MDR, MHRA, PMDA alignment
- How IEC 62304 integrates with ISO 13485 and ISO 14971
- Key definitions: software item, software system, software safety class
- Distinguishing between device software and standalone software applications
- Scope and exclusions: what the standard does and does not cover
- Structure of the standard: clauses, annexes, normative vs informative content
- Understanding the hierarchy of requirements in medical device software
- Role of IEC 62304 in conformity assessment and market access
- Common misconceptions and myths about software compliance
Module 2: Software Safety Classification – Risk-Based Approach - Principles of risk-based software categorisation
- Differences between Class A, B, and C software
- How to determine software safety class using fault analysis
- Interpreting the impact of software failure on patient safety
- Combining software items into systems: classification aggregation rules
- Handling multi-modal devices with varying risk levels
- Use of FMEA and fault tree analysis to support classification decisions
- Documenting the rationale for each classification
- How notified bodies evaluate classification justification
- Common classification errors and how to avoid them
- Managing borderline cases and edge scenarios
- Classification updates during software changes or enhancements
Module 3: Software Development Lifecycle – From Concept to Release - Phases of the IEC 62304 software lifecycle model
- Mapping project timelines to lifecycle activities
- Requirements engineering in regulated environments
- Creating a Software Requirements Specification (SRS)
- Architectural design principles for safety-critical systems
- Software detailed design: best practices and documentation standards
- Developing traceability from requirements to design
- Software unit implementation and coding standards
- Integrating agile and iterative methods within IEC 62304
- Version control strategies that support compliance
- Configuration management and change tracking
- Transition between lifecycle phases: entry and exit criteria
- Gate review processes for moving between stages
- Using stage-gate models to enforce compliance checkpoints
Module 4: Software Verification and Validation - Differences between verification and validation in practice
- Creating a Software Verification Plan (SVP)
- Designing test cases for functional and non-functional requirements
- Static analysis tools and code reviews: meeting objective evidence needs
- Unit testing strategies for safety-class software
- Integration testing: ensuring modules interact correctly
- System-level testing in simulated clinical environments
- Establishing test coverage metrics aligned with software class
- Regression testing protocols for software updates
- Tool qualification for automated testing frameworks
- Handling test failures and deviation reporting
- Traceability between requirements, tests, and results
- Creating a Software Validation Report (SVR)
- Clinical evaluation integration with software validation
- Simulated use testing and human factors alignment
Module 5: Software Maintenance and Problem Resolution - Defining the software maintenance process per IEC 62304
- Differentiating between corrective, adaptive, and perfective maintenance
- Handling field issues, complaints, and adverse events
- Root cause analysis for software defects
- Using CAPA systems to track and resolve software problems
- Risk assessment of proposed software changes
- Change control procedures and documentation requirements
- Determining when a change triggers a new lifecycle
- Impact analysis for software modifications
- Regression testing scope based on change severity
- Documentation updates required for maintenance releases
- Notification requirements for regulatory authorities
- Maintenance planning and scheduling for legacy systems
- Managing end-of-life and software deprecation
Module 6: Software Risk Management Integration - How ISO 14971 integrates with IEC 62304 activities
- Linking software hazards to system-level risk management
- Documenting software-related risks in the Risk Management File
- Failure modes unique to software: infinite loops, data corruption, race conditions
- Detecting residual risks after mitigation
- Software hazard analysis techniques (SHA)
- Using threat modeling to anticipate malicious use or cybersecurity risks
- Validating risk controls implemented in software
- Achieving ALARP (As Low As Reasonably Practicable) for software risks
- Traceability between risk controls and software requirements
- Handling single-fault conditions in software design
- Audit expectations for software risk documentation
Module 7: Software Configuration Management - Establishing a Software Configuration Management Plan (SCMP)
- Identifying configuration items in software projects
- Versioning schemes compliant with regulatory standards
- Branching and merging strategies without compromising traceability
- Selecting configuration management tools for regulated environments
- Access control and change authorisation protocols
- Baseline creation at key lifecycle milestones
- Change requests and tracking through formal systems
- Audit trail requirements for configuration decisions
- Managing third-party and open-source components
- Software bill of materials (SBOM) integration
- Handling legacy code and imported components
Module 8: Software Problem Reporting and Resolution Process - Designing a compliant software problem reporting system
- Integrating with customer support and field data sources
- Triage workflows for incoming software issues
- Severity and priority classification for reported problems
- Escalation paths for critical software failures
- Documentation requirements for problem investigation
- Interfacing with regulatory reporting obligations (e.g., field safety notices)
- Creating permanent records of problem resolution
- Linking problem reports to CAPA and design history files
- KPIs and metrics for monitoring software quality trends
- Annual product review integration
- Using data analytics to predict failure patterns
Module 9: Software Life Cycle Processes and Roles - Overview of all software lifecycle processes in IEC 62304
- Mapping responsibilities to roles: developer, reviewer, approver
- Defining clear ownership for each activity
- Review and approval workflows for documentation
- Ensuring independence of verification activities
- Qualification requirements for software personnel
- Training plans to maintain competency
- Managing outsourced software development
- Supplier qualification for software vendors
- Audit trails for outsourced work
- Contractual obligations and deliverables for third parties
- Transitioning ownership from vendor to internal team
Module 10: Software Tools and Development Environment Qualification - Classifying development tools: automated vs manual, impact on output
- Determining when tool validation is required
- Categorising tools as Type A, B, or C
- Creating a Tool Validation Plan (TVP)
- Executing installation qualification (IQ), operational qualification (OQ)
- Documentation needed for tool validation reports
- Using commercial off-the-shelf (COTS) tools in compliance workflows
- Managing updates and patches to validated tools
- Version control for tool environments
- Cloud-based development platforms and compliance risks
- Containerisation and virtual environments in regulated settings
- Validation of CI/CD pipelines
Module 11: Software Updates and Cybersecurity Considerations - Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- What is IEC 62304 and why it matters in medical device software
- Overview of global regulatory context: FDA, MDR, MHRA, PMDA alignment
- How IEC 62304 integrates with ISO 13485 and ISO 14971
- Key definitions: software item, software system, software safety class
- Distinguishing between device software and standalone software applications
- Scope and exclusions: what the standard does and does not cover
- Structure of the standard: clauses, annexes, normative vs informative content
- Understanding the hierarchy of requirements in medical device software
- Role of IEC 62304 in conformity assessment and market access
- Common misconceptions and myths about software compliance
Module 2: Software Safety Classification – Risk-Based Approach - Principles of risk-based software categorisation
- Differences between Class A, B, and C software
- How to determine software safety class using fault analysis
- Interpreting the impact of software failure on patient safety
- Combining software items into systems: classification aggregation rules
- Handling multi-modal devices with varying risk levels
- Use of FMEA and fault tree analysis to support classification decisions
- Documenting the rationale for each classification
- How notified bodies evaluate classification justification
- Common classification errors and how to avoid them
- Managing borderline cases and edge scenarios
- Classification updates during software changes or enhancements
Module 3: Software Development Lifecycle – From Concept to Release - Phases of the IEC 62304 software lifecycle model
- Mapping project timelines to lifecycle activities
- Requirements engineering in regulated environments
- Creating a Software Requirements Specification (SRS)
- Architectural design principles for safety-critical systems
- Software detailed design: best practices and documentation standards
- Developing traceability from requirements to design
- Software unit implementation and coding standards
- Integrating agile and iterative methods within IEC 62304
- Version control strategies that support compliance
- Configuration management and change tracking
- Transition between lifecycle phases: entry and exit criteria
- Gate review processes for moving between stages
- Using stage-gate models to enforce compliance checkpoints
Module 4: Software Verification and Validation - Differences between verification and validation in practice
- Creating a Software Verification Plan (SVP)
- Designing test cases for functional and non-functional requirements
- Static analysis tools and code reviews: meeting objective evidence needs
- Unit testing strategies for safety-class software
- Integration testing: ensuring modules interact correctly
- System-level testing in simulated clinical environments
- Establishing test coverage metrics aligned with software class
- Regression testing protocols for software updates
- Tool qualification for automated testing frameworks
- Handling test failures and deviation reporting
- Traceability between requirements, tests, and results
- Creating a Software Validation Report (SVR)
- Clinical evaluation integration with software validation
- Simulated use testing and human factors alignment
Module 5: Software Maintenance and Problem Resolution - Defining the software maintenance process per IEC 62304
- Differentiating between corrective, adaptive, and perfective maintenance
- Handling field issues, complaints, and adverse events
- Root cause analysis for software defects
- Using CAPA systems to track and resolve software problems
- Risk assessment of proposed software changes
- Change control procedures and documentation requirements
- Determining when a change triggers a new lifecycle
- Impact analysis for software modifications
- Regression testing scope based on change severity
- Documentation updates required for maintenance releases
- Notification requirements for regulatory authorities
- Maintenance planning and scheduling for legacy systems
- Managing end-of-life and software deprecation
Module 6: Software Risk Management Integration - How ISO 14971 integrates with IEC 62304 activities
- Linking software hazards to system-level risk management
- Documenting software-related risks in the Risk Management File
- Failure modes unique to software: infinite loops, data corruption, race conditions
- Detecting residual risks after mitigation
- Software hazard analysis techniques (SHA)
- Using threat modeling to anticipate malicious use or cybersecurity risks
- Validating risk controls implemented in software
- Achieving ALARP (As Low As Reasonably Practicable) for software risks
- Traceability between risk controls and software requirements
- Handling single-fault conditions in software design
- Audit expectations for software risk documentation
Module 7: Software Configuration Management - Establishing a Software Configuration Management Plan (SCMP)
- Identifying configuration items in software projects
- Versioning schemes compliant with regulatory standards
- Branching and merging strategies without compromising traceability
- Selecting configuration management tools for regulated environments
- Access control and change authorisation protocols
- Baseline creation at key lifecycle milestones
- Change requests and tracking through formal systems
- Audit trail requirements for configuration decisions
- Managing third-party and open-source components
- Software bill of materials (SBOM) integration
- Handling legacy code and imported components
Module 8: Software Problem Reporting and Resolution Process - Designing a compliant software problem reporting system
- Integrating with customer support and field data sources
- Triage workflows for incoming software issues
- Severity and priority classification for reported problems
- Escalation paths for critical software failures
- Documentation requirements for problem investigation
- Interfacing with regulatory reporting obligations (e.g., field safety notices)
- Creating permanent records of problem resolution
- Linking problem reports to CAPA and design history files
- KPIs and metrics for monitoring software quality trends
- Annual product review integration
- Using data analytics to predict failure patterns
Module 9: Software Life Cycle Processes and Roles - Overview of all software lifecycle processes in IEC 62304
- Mapping responsibilities to roles: developer, reviewer, approver
- Defining clear ownership for each activity
- Review and approval workflows for documentation
- Ensuring independence of verification activities
- Qualification requirements for software personnel
- Training plans to maintain competency
- Managing outsourced software development
- Supplier qualification for software vendors
- Audit trails for outsourced work
- Contractual obligations and deliverables for third parties
- Transitioning ownership from vendor to internal team
Module 10: Software Tools and Development Environment Qualification - Classifying development tools: automated vs manual, impact on output
- Determining when tool validation is required
- Categorising tools as Type A, B, or C
- Creating a Tool Validation Plan (TVP)
- Executing installation qualification (IQ), operational qualification (OQ)
- Documentation needed for tool validation reports
- Using commercial off-the-shelf (COTS) tools in compliance workflows
- Managing updates and patches to validated tools
- Version control for tool environments
- Cloud-based development platforms and compliance risks
- Containerisation and virtual environments in regulated settings
- Validation of CI/CD pipelines
Module 11: Software Updates and Cybersecurity Considerations - Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Phases of the IEC 62304 software lifecycle model
- Mapping project timelines to lifecycle activities
- Requirements engineering in regulated environments
- Creating a Software Requirements Specification (SRS)
- Architectural design principles for safety-critical systems
- Software detailed design: best practices and documentation standards
- Developing traceability from requirements to design
- Software unit implementation and coding standards
- Integrating agile and iterative methods within IEC 62304
- Version control strategies that support compliance
- Configuration management and change tracking
- Transition between lifecycle phases: entry and exit criteria
- Gate review processes for moving between stages
- Using stage-gate models to enforce compliance checkpoints
Module 4: Software Verification and Validation - Differences between verification and validation in practice
- Creating a Software Verification Plan (SVP)
- Designing test cases for functional and non-functional requirements
- Static analysis tools and code reviews: meeting objective evidence needs
- Unit testing strategies for safety-class software
- Integration testing: ensuring modules interact correctly
- System-level testing in simulated clinical environments
- Establishing test coverage metrics aligned with software class
- Regression testing protocols for software updates
- Tool qualification for automated testing frameworks
- Handling test failures and deviation reporting
- Traceability between requirements, tests, and results
- Creating a Software Validation Report (SVR)
- Clinical evaluation integration with software validation
- Simulated use testing and human factors alignment
Module 5: Software Maintenance and Problem Resolution - Defining the software maintenance process per IEC 62304
- Differentiating between corrective, adaptive, and perfective maintenance
- Handling field issues, complaints, and adverse events
- Root cause analysis for software defects
- Using CAPA systems to track and resolve software problems
- Risk assessment of proposed software changes
- Change control procedures and documentation requirements
- Determining when a change triggers a new lifecycle
- Impact analysis for software modifications
- Regression testing scope based on change severity
- Documentation updates required for maintenance releases
- Notification requirements for regulatory authorities
- Maintenance planning and scheduling for legacy systems
- Managing end-of-life and software deprecation
Module 6: Software Risk Management Integration - How ISO 14971 integrates with IEC 62304 activities
- Linking software hazards to system-level risk management
- Documenting software-related risks in the Risk Management File
- Failure modes unique to software: infinite loops, data corruption, race conditions
- Detecting residual risks after mitigation
- Software hazard analysis techniques (SHA)
- Using threat modeling to anticipate malicious use or cybersecurity risks
- Validating risk controls implemented in software
- Achieving ALARP (As Low As Reasonably Practicable) for software risks
- Traceability between risk controls and software requirements
- Handling single-fault conditions in software design
- Audit expectations for software risk documentation
Module 7: Software Configuration Management - Establishing a Software Configuration Management Plan (SCMP)
- Identifying configuration items in software projects
- Versioning schemes compliant with regulatory standards
- Branching and merging strategies without compromising traceability
- Selecting configuration management tools for regulated environments
- Access control and change authorisation protocols
- Baseline creation at key lifecycle milestones
- Change requests and tracking through formal systems
- Audit trail requirements for configuration decisions
- Managing third-party and open-source components
- Software bill of materials (SBOM) integration
- Handling legacy code and imported components
Module 8: Software Problem Reporting and Resolution Process - Designing a compliant software problem reporting system
- Integrating with customer support and field data sources
- Triage workflows for incoming software issues
- Severity and priority classification for reported problems
- Escalation paths for critical software failures
- Documentation requirements for problem investigation
- Interfacing with regulatory reporting obligations (e.g., field safety notices)
- Creating permanent records of problem resolution
- Linking problem reports to CAPA and design history files
- KPIs and metrics for monitoring software quality trends
- Annual product review integration
- Using data analytics to predict failure patterns
Module 9: Software Life Cycle Processes and Roles - Overview of all software lifecycle processes in IEC 62304
- Mapping responsibilities to roles: developer, reviewer, approver
- Defining clear ownership for each activity
- Review and approval workflows for documentation
- Ensuring independence of verification activities
- Qualification requirements for software personnel
- Training plans to maintain competency
- Managing outsourced software development
- Supplier qualification for software vendors
- Audit trails for outsourced work
- Contractual obligations and deliverables for third parties
- Transitioning ownership from vendor to internal team
Module 10: Software Tools and Development Environment Qualification - Classifying development tools: automated vs manual, impact on output
- Determining when tool validation is required
- Categorising tools as Type A, B, or C
- Creating a Tool Validation Plan (TVP)
- Executing installation qualification (IQ), operational qualification (OQ)
- Documentation needed for tool validation reports
- Using commercial off-the-shelf (COTS) tools in compliance workflows
- Managing updates and patches to validated tools
- Version control for tool environments
- Cloud-based development platforms and compliance risks
- Containerisation and virtual environments in regulated settings
- Validation of CI/CD pipelines
Module 11: Software Updates and Cybersecurity Considerations - Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Defining the software maintenance process per IEC 62304
- Differentiating between corrective, adaptive, and perfective maintenance
- Handling field issues, complaints, and adverse events
- Root cause analysis for software defects
- Using CAPA systems to track and resolve software problems
- Risk assessment of proposed software changes
- Change control procedures and documentation requirements
- Determining when a change triggers a new lifecycle
- Impact analysis for software modifications
- Regression testing scope based on change severity
- Documentation updates required for maintenance releases
- Notification requirements for regulatory authorities
- Maintenance planning and scheduling for legacy systems
- Managing end-of-life and software deprecation
Module 6: Software Risk Management Integration - How ISO 14971 integrates with IEC 62304 activities
- Linking software hazards to system-level risk management
- Documenting software-related risks in the Risk Management File
- Failure modes unique to software: infinite loops, data corruption, race conditions
- Detecting residual risks after mitigation
- Software hazard analysis techniques (SHA)
- Using threat modeling to anticipate malicious use or cybersecurity risks
- Validating risk controls implemented in software
- Achieving ALARP (As Low As Reasonably Practicable) for software risks
- Traceability between risk controls and software requirements
- Handling single-fault conditions in software design
- Audit expectations for software risk documentation
Module 7: Software Configuration Management - Establishing a Software Configuration Management Plan (SCMP)
- Identifying configuration items in software projects
- Versioning schemes compliant with regulatory standards
- Branching and merging strategies without compromising traceability
- Selecting configuration management tools for regulated environments
- Access control and change authorisation protocols
- Baseline creation at key lifecycle milestones
- Change requests and tracking through formal systems
- Audit trail requirements for configuration decisions
- Managing third-party and open-source components
- Software bill of materials (SBOM) integration
- Handling legacy code and imported components
Module 8: Software Problem Reporting and Resolution Process - Designing a compliant software problem reporting system
- Integrating with customer support and field data sources
- Triage workflows for incoming software issues
- Severity and priority classification for reported problems
- Escalation paths for critical software failures
- Documentation requirements for problem investigation
- Interfacing with regulatory reporting obligations (e.g., field safety notices)
- Creating permanent records of problem resolution
- Linking problem reports to CAPA and design history files
- KPIs and metrics for monitoring software quality trends
- Annual product review integration
- Using data analytics to predict failure patterns
Module 9: Software Life Cycle Processes and Roles - Overview of all software lifecycle processes in IEC 62304
- Mapping responsibilities to roles: developer, reviewer, approver
- Defining clear ownership for each activity
- Review and approval workflows for documentation
- Ensuring independence of verification activities
- Qualification requirements for software personnel
- Training plans to maintain competency
- Managing outsourced software development
- Supplier qualification for software vendors
- Audit trails for outsourced work
- Contractual obligations and deliverables for third parties
- Transitioning ownership from vendor to internal team
Module 10: Software Tools and Development Environment Qualification - Classifying development tools: automated vs manual, impact on output
- Determining when tool validation is required
- Categorising tools as Type A, B, or C
- Creating a Tool Validation Plan (TVP)
- Executing installation qualification (IQ), operational qualification (OQ)
- Documentation needed for tool validation reports
- Using commercial off-the-shelf (COTS) tools in compliance workflows
- Managing updates and patches to validated tools
- Version control for tool environments
- Cloud-based development platforms and compliance risks
- Containerisation and virtual environments in regulated settings
- Validation of CI/CD pipelines
Module 11: Software Updates and Cybersecurity Considerations - Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Establishing a Software Configuration Management Plan (SCMP)
- Identifying configuration items in software projects
- Versioning schemes compliant with regulatory standards
- Branching and merging strategies without compromising traceability
- Selecting configuration management tools for regulated environments
- Access control and change authorisation protocols
- Baseline creation at key lifecycle milestones
- Change requests and tracking through formal systems
- Audit trail requirements for configuration decisions
- Managing third-party and open-source components
- Software bill of materials (SBOM) integration
- Handling legacy code and imported components
Module 8: Software Problem Reporting and Resolution Process - Designing a compliant software problem reporting system
- Integrating with customer support and field data sources
- Triage workflows for incoming software issues
- Severity and priority classification for reported problems
- Escalation paths for critical software failures
- Documentation requirements for problem investigation
- Interfacing with regulatory reporting obligations (e.g., field safety notices)
- Creating permanent records of problem resolution
- Linking problem reports to CAPA and design history files
- KPIs and metrics for monitoring software quality trends
- Annual product review integration
- Using data analytics to predict failure patterns
Module 9: Software Life Cycle Processes and Roles - Overview of all software lifecycle processes in IEC 62304
- Mapping responsibilities to roles: developer, reviewer, approver
- Defining clear ownership for each activity
- Review and approval workflows for documentation
- Ensuring independence of verification activities
- Qualification requirements for software personnel
- Training plans to maintain competency
- Managing outsourced software development
- Supplier qualification for software vendors
- Audit trails for outsourced work
- Contractual obligations and deliverables for third parties
- Transitioning ownership from vendor to internal team
Module 10: Software Tools and Development Environment Qualification - Classifying development tools: automated vs manual, impact on output
- Determining when tool validation is required
- Categorising tools as Type A, B, or C
- Creating a Tool Validation Plan (TVP)
- Executing installation qualification (IQ), operational qualification (OQ)
- Documentation needed for tool validation reports
- Using commercial off-the-shelf (COTS) tools in compliance workflows
- Managing updates and patches to validated tools
- Version control for tool environments
- Cloud-based development platforms and compliance risks
- Containerisation and virtual environments in regulated settings
- Validation of CI/CD pipelines
Module 11: Software Updates and Cybersecurity Considerations - Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Overview of all software lifecycle processes in IEC 62304
- Mapping responsibilities to roles: developer, reviewer, approver
- Defining clear ownership for each activity
- Review and approval workflows for documentation
- Ensuring independence of verification activities
- Qualification requirements for software personnel
- Training plans to maintain competency
- Managing outsourced software development
- Supplier qualification for software vendors
- Audit trails for outsourced work
- Contractual obligations and deliverables for third parties
- Transitioning ownership from vendor to internal team
Module 10: Software Tools and Development Environment Qualification - Classifying development tools: automated vs manual, impact on output
- Determining when tool validation is required
- Categorising tools as Type A, B, or C
- Creating a Tool Validation Plan (TVP)
- Executing installation qualification (IQ), operational qualification (OQ)
- Documentation needed for tool validation reports
- Using commercial off-the-shelf (COTS) tools in compliance workflows
- Managing updates and patches to validated tools
- Version control for tool environments
- Cloud-based development platforms and compliance risks
- Containerisation and virtual environments in regulated settings
- Validation of CI/CD pipelines
Module 11: Software Updates and Cybersecurity Considerations - Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Managing planned and emergency software updates
- Remote update capabilities and regulatory implications
- Secure boot, code signing, and tamper detection mechanisms
- Integrating IEC 80001 principles for networked devices
- Handling vulnerabilities disclosed in open-source libraries
- Coordinating with coordinated vulnerability disclosure (CVD) programs
- Designing secure authentication for software access
- Data encryption in transit and at rest
- Logging and monitoring for unauthorised access
- Penetration testing and red teaming in compliance contexts
- Documenting cybersecurity risk controls in technical files
- Preparing for forthcoming regulations like EU MDR cybersecurity requirements
Module 12: Documentation and Audit Readiness - Essential documents required by IEC 62304
- Creating a Software Development Plan (SDP)
- Software Design Specification (SDS): structure and content
- Software Installation and Maintenance Instructions (SIMI)
- Software Problem Management Report (SPMR)
- Traceability matrix best practices
- Using templates to standardise documentation across teams
- Document control: revision management, approvals, retention
- Preparing for internal audits and external assessments
- Responding to auditor questions about software compliance
- Simulating mock audits using real-world checklists
- Building an index of evidence for notified body submissions
- Minimising documentation gaps before certification
- Electronic records compliance with 21 CFR Part 11 and EU Annex 11
Module 13: IEC 62304 for Agile and Iterative Development - Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Challenges of applying waterfall-based standards to agile teams
- Mapping sprints to IEC 62304 lifecycle phases
- Backlog grooming with compliance traceability in mind
- User stories and acceptance criteria that meet regulatory requirements
- Maintaining audit trails in Jira, Azure DevOps, or similar tools
- Sprint reviews as phase gate demonstrations
- Release planning and version freeze strategies
- Incorporating risk reviews into sprint retrospectives
- Combining continuous integration with formal verification
- Ensuring independence of testing in fast-moving teams
- Documentation efficiency: avoiding duplication while maintaining traceability
- Using living documents that evolve with the product
Module 14: Software of Unknown Provenance (SOUP) - Definition and scope of SOUP in IEC 62304
- Assessing risks associated with third-party and legacy code
- Controls required when integrating SOUP into safety-class software
- Validation strategies for unverified components
- Creating a SOUP assessment report
- Supplier declarations of conformity and their limitations
- Using static analysis to detect vulnerabilities in SOUP
- Defining boundaries and wrappers around SOUP elements
- Runtime monitoring to detect SOUP failures
- Audit expectations for SOUP risk mitigation
- Documentation required for regulatory submissions
- Managing open-source libraries as SOUP
Module 15: Advanced Implementation Scenarios - Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- Handling software in SaMD (Software as a Medical Device)
- Multi-platform applications: mobile, cloud, embedded
- Differences between firmware, embedded software, and application layers
- Distributed systems and microservices architectures
- AI/ML-based software: challenges for validation and lifecycle control
- Managing model drift and retraining cycles
- Defining fixed vs adaptive algorithms for regulatory purposes
- Real-world performance monitoring and post-market surveillance
- Updating machine learning models under IEC 62304 constraints
- Handling edge devices with local inference capabilities
- Interoperability with EHRs and health information systems
- Ensuring consistency across device ecosystems
Module 16: Integration with Quality Management Systems - Embedding IEC 62304 processes into the QMS
- Aligning software development with design controls
- Linking software activities to DHF and DMR requirements
- Management review inputs for software performance
- Resource planning for software teams
- Document management system integration
- Training records for software developers and reviewers
- Internal audit checklists for software processes
- Cross-functional communication protocols
- Corrective action workflows tied to software defects
- KPI dashboards for tracking software quality metrics
- Preparing for Stage 2 audits with full process alignment
Module 17: Regulatory Submissions and Notified Body Interaction - What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators
Module 18: Certification Preparation and Next Steps - Self-assessment checklist: are you audit-ready?
- Gap analysis template for internal reviews
- Finalising your Certificate of Completion requirements
- Submitting your project portfolio for assessment
- Receiving your Certificate of Completion from The Art of Service
- Verifying your credential via official portal
- Adding the credential to LinkedIn and CV
- Using the certificate in job applications and promotions
- Accessing alumni resources and industry updates
- Joining the global network of certified professionals
- Continuing education pathways in MedTech compliance
- Next-level certifications to pursue after mastery
- Lifetime access renewal and update notifications
- Ongoing support for implementation challenges
- What auditors look for in software documentation
- Preparing technical documentation for MDR and FDA submissions
- Structuring the software section of the Technical File
- Using tables, diagrams, and matrices to enhance clarity
- Responding to audit findings and deficiency letters
- Handling requests for additional information
- Presenting lifecycle evidence logically and chronologically
- Explaining deviations and process adaptations transparently
- Benchmarking against competitor submissions
- Working with consultants and notified bodies effectively
- Preparing for unannounced audits
- Conducting pre-submission meetings with regulators