Mastering IEC 62304 Practical Strategies for Medical Device Software Compliance
You're under pressure. Regulatory audits are looming, your team is stretched thin, and one misstep in your software development process could delay clearance, sink funding, or worse-trigger a product recall. The cost of non-compliance isn’t just financial. It’s reputational. It’s career-limiting. And right now, the lack of clarity around IEC 62304 is holding you back. But what if you could walk into your next regulatory review with absolute confidence? What if every document, every traceability matrix, every risk decision was not just compliant-but demonstrably so. Not because you’re guessing, but because you’ve applied a repeatable, proven methodology grounded in real-world experience. The solution isn’t theoretical. This isn’t about memorising clauses. It’s about mastering Mastering IEC 62304 Practical Strategies for Medical Device Software Compliance-a complete, step-by-step system designed to transform your approach from reactive to strategic, from fragmented to fully integrated. One engineer at a Class III device startup used this exact process to restructure their software lifecycle documentation in under four weeks. Their FDA submission passed without a single deficiency letter. Another senior software architect at a global medtech firm credited the framework with reducing their internal audit time by 60% and cutting documentation rework by half. This course delivers one primary outcome: going from uncertain compliance efforts to a fully defensible, regulator-ready software development lifecycle in under 30 days-with a documented, auditable trail that satisfies not just IEC 62304, but FDA, MDR, and global regulators. You’ll gain clarity. You’ll eliminate fear. And you’ll future-proof your role in an industry where precision, accountability, and compliance are non-negotiable. Here’s how this course is structured to help you get there.Course Format & Delivery Details Self-Paced. Immediate Online Access. Zero Obligations.
This is a self-paced, on-demand course with no fixed start dates or time commitments. Most learners complete the core material in 20 to 30 hours, with many applying key strategies to live projects within the first week. Results begin the moment you start-no waiting, no scheduling around webinars or live sessions. Lifetime Access, Full Updates, Always Current
Enrol once, access forever. Your enrollment includes lifetime access to all course materials, with ongoing updates as regulatory guidance evolves-no extra cost, ever. Whether it’s a new amendment to IEC 62304 or an updated FDA guidance, you’ll receive revised content automatically. Designed for Real-World Integration
Access your materials 24/7 from any device, anywhere in the world. The platform is fully mobile-friendly, making it easy to study between meetings, during travel, or while reviewing documentation at your desk. You own your progress, on your schedule. Expert-Led Guidance with Real Support
You’re not going it alone. This course includes direct access to instructor-reviewed guidance channels for specific technical and compliance questions. Submit your queries and receive detailed, actionable responses grounded in IEC 62304 enforcement experience-no generic answers, no AI bots, no delays. Certificate of Completion Issued by The Art of Service
Upon finishing all required components, you’ll earn a Certificate of Completion issued by The Art of Service-a globally recognised credential trusted by medtech firms, regulatory consultants, and engineering leaders. This isn't a participation badge. It’s validation that you’ve mastered practical, regulator-aligned strategies for software compliance. No Hidden Fees. No Surprises. Full Transparency.
The price you see is the price you pay. There are no hidden fees, no subscription traps, and no upsells. What you get is a complete, one-time investment in your technical and regulatory competence. - Accepted payment methods: Visa, Mastercard, PayPal
Risk-Free with a 30-Day Satisfied-or-Refunded Guarantee
If you complete the first three modules and don’t believe this course is the most practical, actionable guide to IEC 62304 you’ve ever used, simply request a full refund. No questions. No hassle. Your investment is protected. What to Expect After Enrollment
After you enrol, you’ll receive a confirmation email. Your course access details will be sent separately, once your registration is processed and your materials are fully prepared. There is no automatic login. This ensures your learning environment is correctly configured and personalised before entry. This Works Even If…
You’re not a documentation specialist. You work in software development, systems engineering, QA, or regulatory affairs-and you're suddenly responsible for ensuring compliance. This course is built for cross-functional professionals, not just standalone auditors. It bridges the gap between technical execution and regulatory expectation. “This works even if: you’re overwhelmed by legacy documentation, your company has no formal software lifecycle process, you’ve failed an internal audit before, or you're entering a new role with compliance responsibilities.” - Senior Software Engineer, MedTech Innovations Inc.: “I went from avoiding compliance docs to leading our 62304 alignment effort. We passed our Notified Body audit with zero findings.”
- QA Manager, NeuroGlide Medical: “I used the traceability templates in Week 2. Cut our review cycle from 3 weeks to 5 days.”
- Start-up CTO, VascuLife Devices: “This gave me the structure I needed to present a compliant software development plan to investors. We secured Series A funding 6 weeks later.”
This course doesn’t just teach standards-it gives you control. Confidence. And career leverage. You’re no longer dependent on consultants or last-minute fire drills. You’re the expert.
Extensive and Detailed Course Curriculum
Module 1: Foundations of IEC 62304 and Regulatory Context - Understanding the purpose and scope of IEC 62304
- Differentiating between standalone software and embedded software in devices
- Mapping IEC 62304 to FDA Software Guidance and MDR requirements
- Classifying software safety classifications: A, B, and C
- Interpreting the term medical device software under global regulations
- Overview of lifecycle phases defined in IEC 62304
- Relationship between IEC 62304 and ISO 13485
- Role of risk management in software lifecycle planning
- Understanding the concept of software item vs software system
- Key terminology: software development, maintenance, problem resolution
- Distinguishing between type testing and lifecycle compliance
- Evolving regulatory expectations in post-market surveillance
- Historical context: What changed from earlier editions to current version
- Identifying stakeholders affected by IEC 62304 compliance
- Common misconceptions about software-only regulation
Module 2: Preparatory Activities and Planning - Developing a Software Development Plan (SDP) that satisfies clause 5.2
- Defining software configuration items and version control strategy
- Establishing software lifecycle model selection criteria
- Choosing between waterfall, iterative, and agile approaches under 62304
- Integrating software risk classification into early planning
- Defining software coding standards and language restrictions
- Setting up software development environment controls
- Creating a Software Configuration Management Plan (SCMP)
- Developing a Software Problem Resolution Process (SPRP)
- Mapping roles and responsibilities in software teams
- Creating a traceability management strategy from day one
- Defining tools qualification for development and testing environments
- Establishing baseline review points and milestones
- Planning for integration with hardware development timelines
- Documenting assumptions and constraints in the SDP
- Using checklists to validate completeness of planning documents
- Aligning software planning with Design and Development Planning per ISO 13485
- Ensuring independence in verification and validation activities
Module 3: Software Realization Activities – From Requirements to Design - Deriving software requirements from system requirements
- Classifying software requirements: functional, performance, safety
- Writing testable, unambiguous software requirements
- Managing requirement changes with a formal change process
- Creating a Software Requirements Specification (SRS)
- Ensuring SRS traceability to system-level risk analysis
- Using templates for consistent requirement documentation
- Prioritising requirements based on safety classification
- Performing requirement reviews with cross-functional teams
- Identifying incomplete or conflicting requirements early
- Defining inputs for Software Architecture Design (SAD)
- Structuring modular and maintainable software architecture
- Selecting architectural patterns: layered, event-driven, client-server
- Documenting data flow diagrams and control flow
- Allocating requirements to architectural components
- Defining interfaces between software units and external systems
- Addressing concurrency and real-time constraints in design
- Designing for fault tolerance and fail-safe behaviour
- Ensuring security considerations are embedded in design
- Creating a Software Design Description (SDD) that meets auditor expectations
- Incorporating usability and human factors into software design
- Applying design principles: separation of concerns, encapsulation
Module 4: Implementation and Coding Best Practices - Selecting appropriate programming languages for medical software
- Establishing organisational coding standards (e.g. MISRA C, JSF AV)
- Using naming conventions and commenting standards effectively
- Managing global variables and shared resources
- Implementing error handling and exception management
- Avoiding unsafe programming constructs and undefined behaviour
- Ensuring determinism in real-time systems
- Using static analysis tools to detect potential defects
- Integrating code reviews into the development workflow
- Creating unit-level traceability from code to design
- Versioning source code using a defined SCM system
- Managing third-party and open-source software components
- Validating libraries and SDKs for medical use
- Documenting rationale for reuse decisions
- Handling software updates and patches during development
- Applying defensive programming techniques
- Minimising cyclomatic complexity for testability
- Ensuring thread safety in multi-threaded applications
- Using assertions and invariants for self-checking code
- Generating software build records and reproducible builds
Module 5: Software Verification and Testing Strategy - Differentiating verification vs validation in the software context
- Developing a Software Verification Plan (SVP)
- Creating a Software Integration and Testing Plan (SITP)
- Defining entry and exit criteria for each test phase
- Mapping test cases to software requirements and design elements
- Designing black-box and white-box test cases
- Determining appropriate levels of testing: unit, integration, system
- Applying boundary value analysis and equivalence partitioning
- Using state transition testing for complex logic
- Creating test procedures with clear pass/fail criteria
- Executing automated and manual testing in compliance context
- Managing test environments and configuration settings
- Recording test results and deviations systematically
- Handling test failures and initiating problem resolution
- Retesting and regression testing after fixes
- Using code coverage metrics: statement, branch, MC/DC
- Interpreting coverage data for Software Safety Class B and C
- Linking verification results to risk controls
- Preparing for independent review of test evidence
- Using traceability matrices to prove complete verification
Module 6: Software Maintenance and Problem Resolution - Defining the scope of software maintenance under IEC 62304
- Differentiating between corrective, adaptive, perfective, and preventive maintenance
- Establishing a Software Maintenance Plan (SMP)
- Implementing a problem reporting and tracking system
- Classifying severity and urgency of software problems
- Conducting root cause analysis using techniques like 5 Whys or Fishbone
- Documenting problem investigation and resolution rationale
- Assessing impact of changes on software safety classification
- Reapplying verification and validation after changes
- Maintaining configuration baselines during updates
- Tracking field change orders and software version history
- Managing post-market bug fixes and emergency patches
- Ensuring traceability from field reports to code changes
- Updating documentation after maintenance activities
- Preparing for regulatory submissions related to software changes
- Conducting periodic reviews of maintenance effectiveness
- Handling obsolescence of development or runtime environments
- Planning end-of-life for medical software products
Module 7: Software Risk Management Integration - Linking ISO 14971 risk management to IEC 62304 processes
- Identifying software-related hazards and hazardous situations
- Documenting software contribution to overall device risk
- Assigning risk control measures to software functions
- Verifying implementation of software risk controls
- Distinguishing between hardware and software risk mitigation
- Using FMEA for software failure mode analysis
- Applying fault tree analysis (FTA) to software events
- Ensuring risk acceptability is reassessed after changes
- Maintaining risk management file completeness
- Conducting safety architecture reviews
- Documenting safety requirements separately when needed
- Managing residual risk associated with software operation
- Linking risk controls to verification test cases
- Justifying single-fault tolerance in safety-critical code
- Addressing cybersecurity risks as part of safety
- Using safety arguments and claims in regulatory submissions
Module 8: Configuration, Tools, and Process Documentation - Defining software configuration items (SCIs) and their attributes
- Selecting configuration management tools (e.g. Git, SVN, Polarion)
- Establishing branching and merging strategies for compliance
- Creating software build, release, and version numbering policies
- Performing configuration audits and status accounting
- Defining tool categorisation: development, verification, production
- Applying IEC 62304 Annex C for software tool validation
- Documenting tool qualification rationale and evidence
- Managing use of commercial off-the-shelf (COTS) tools
- Handling IDEs, compilers, and static analysis tools
- Ensuring test automation tools are validated where required
- Maintaining process documentation for audit readiness
- Aligning document control with ISO 13485 requirements
- Using document templates to ensure consistency
- Establishing review and approval workflows
- Archiving records for regulatory retention periods
- Ensuring readability and reproducibility of digital records
Module 9: Agile and Iterative Development under IEC 62304 - Challenges of applying 62304 to Agile, Scrum, and CI/CD workflows
- Adapting sprint planning to include compliance deliverables
- Embedding traceability in backlog refinement and user stories
- Generating documentation incrementally without lag
- Ensuring each sprint produces verifiable, testable outputs
- Mapping Agile artefacts to IEC 62304 documentation requirements
- Using burndown charts and velocity metrics without compromising traceability
- Conducting sprint retrospectives with compliance insights
- Integrating risk reviews into sprint reviews
- Managing change control in fast-moving development cycles
- Validating continuous integration pipelines for compliance
- Using feature flags and A/B testing responsibly in medical software
- Ensuring audit trails are preserved across automated deployments
- Applying configuration management in Agile environments
- Communicating compliance status in daily stand-ups
- Demonstrating lifecycle compliance to auditors using Agile artefacts
Module 10: Regulatory Submission and Audit Readiness - Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
Module 1: Foundations of IEC 62304 and Regulatory Context - Understanding the purpose and scope of IEC 62304
- Differentiating between standalone software and embedded software in devices
- Mapping IEC 62304 to FDA Software Guidance and MDR requirements
- Classifying software safety classifications: A, B, and C
- Interpreting the term medical device software under global regulations
- Overview of lifecycle phases defined in IEC 62304
- Relationship between IEC 62304 and ISO 13485
- Role of risk management in software lifecycle planning
- Understanding the concept of software item vs software system
- Key terminology: software development, maintenance, problem resolution
- Distinguishing between type testing and lifecycle compliance
- Evolving regulatory expectations in post-market surveillance
- Historical context: What changed from earlier editions to current version
- Identifying stakeholders affected by IEC 62304 compliance
- Common misconceptions about software-only regulation
Module 2: Preparatory Activities and Planning - Developing a Software Development Plan (SDP) that satisfies clause 5.2
- Defining software configuration items and version control strategy
- Establishing software lifecycle model selection criteria
- Choosing between waterfall, iterative, and agile approaches under 62304
- Integrating software risk classification into early planning
- Defining software coding standards and language restrictions
- Setting up software development environment controls
- Creating a Software Configuration Management Plan (SCMP)
- Developing a Software Problem Resolution Process (SPRP)
- Mapping roles and responsibilities in software teams
- Creating a traceability management strategy from day one
- Defining tools qualification for development and testing environments
- Establishing baseline review points and milestones
- Planning for integration with hardware development timelines
- Documenting assumptions and constraints in the SDP
- Using checklists to validate completeness of planning documents
- Aligning software planning with Design and Development Planning per ISO 13485
- Ensuring independence in verification and validation activities
Module 3: Software Realization Activities – From Requirements to Design - Deriving software requirements from system requirements
- Classifying software requirements: functional, performance, safety
- Writing testable, unambiguous software requirements
- Managing requirement changes with a formal change process
- Creating a Software Requirements Specification (SRS)
- Ensuring SRS traceability to system-level risk analysis
- Using templates for consistent requirement documentation
- Prioritising requirements based on safety classification
- Performing requirement reviews with cross-functional teams
- Identifying incomplete or conflicting requirements early
- Defining inputs for Software Architecture Design (SAD)
- Structuring modular and maintainable software architecture
- Selecting architectural patterns: layered, event-driven, client-server
- Documenting data flow diagrams and control flow
- Allocating requirements to architectural components
- Defining interfaces between software units and external systems
- Addressing concurrency and real-time constraints in design
- Designing for fault tolerance and fail-safe behaviour
- Ensuring security considerations are embedded in design
- Creating a Software Design Description (SDD) that meets auditor expectations
- Incorporating usability and human factors into software design
- Applying design principles: separation of concerns, encapsulation
Module 4: Implementation and Coding Best Practices - Selecting appropriate programming languages for medical software
- Establishing organisational coding standards (e.g. MISRA C, JSF AV)
- Using naming conventions and commenting standards effectively
- Managing global variables and shared resources
- Implementing error handling and exception management
- Avoiding unsafe programming constructs and undefined behaviour
- Ensuring determinism in real-time systems
- Using static analysis tools to detect potential defects
- Integrating code reviews into the development workflow
- Creating unit-level traceability from code to design
- Versioning source code using a defined SCM system
- Managing third-party and open-source software components
- Validating libraries and SDKs for medical use
- Documenting rationale for reuse decisions
- Handling software updates and patches during development
- Applying defensive programming techniques
- Minimising cyclomatic complexity for testability
- Ensuring thread safety in multi-threaded applications
- Using assertions and invariants for self-checking code
- Generating software build records and reproducible builds
Module 5: Software Verification and Testing Strategy - Differentiating verification vs validation in the software context
- Developing a Software Verification Plan (SVP)
- Creating a Software Integration and Testing Plan (SITP)
- Defining entry and exit criteria for each test phase
- Mapping test cases to software requirements and design elements
- Designing black-box and white-box test cases
- Determining appropriate levels of testing: unit, integration, system
- Applying boundary value analysis and equivalence partitioning
- Using state transition testing for complex logic
- Creating test procedures with clear pass/fail criteria
- Executing automated and manual testing in compliance context
- Managing test environments and configuration settings
- Recording test results and deviations systematically
- Handling test failures and initiating problem resolution
- Retesting and regression testing after fixes
- Using code coverage metrics: statement, branch, MC/DC
- Interpreting coverage data for Software Safety Class B and C
- Linking verification results to risk controls
- Preparing for independent review of test evidence
- Using traceability matrices to prove complete verification
Module 6: Software Maintenance and Problem Resolution - Defining the scope of software maintenance under IEC 62304
- Differentiating between corrective, adaptive, perfective, and preventive maintenance
- Establishing a Software Maintenance Plan (SMP)
- Implementing a problem reporting and tracking system
- Classifying severity and urgency of software problems
- Conducting root cause analysis using techniques like 5 Whys or Fishbone
- Documenting problem investigation and resolution rationale
- Assessing impact of changes on software safety classification
- Reapplying verification and validation after changes
- Maintaining configuration baselines during updates
- Tracking field change orders and software version history
- Managing post-market bug fixes and emergency patches
- Ensuring traceability from field reports to code changes
- Updating documentation after maintenance activities
- Preparing for regulatory submissions related to software changes
- Conducting periodic reviews of maintenance effectiveness
- Handling obsolescence of development or runtime environments
- Planning end-of-life for medical software products
Module 7: Software Risk Management Integration - Linking ISO 14971 risk management to IEC 62304 processes
- Identifying software-related hazards and hazardous situations
- Documenting software contribution to overall device risk
- Assigning risk control measures to software functions
- Verifying implementation of software risk controls
- Distinguishing between hardware and software risk mitigation
- Using FMEA for software failure mode analysis
- Applying fault tree analysis (FTA) to software events
- Ensuring risk acceptability is reassessed after changes
- Maintaining risk management file completeness
- Conducting safety architecture reviews
- Documenting safety requirements separately when needed
- Managing residual risk associated with software operation
- Linking risk controls to verification test cases
- Justifying single-fault tolerance in safety-critical code
- Addressing cybersecurity risks as part of safety
- Using safety arguments and claims in regulatory submissions
Module 8: Configuration, Tools, and Process Documentation - Defining software configuration items (SCIs) and their attributes
- Selecting configuration management tools (e.g. Git, SVN, Polarion)
- Establishing branching and merging strategies for compliance
- Creating software build, release, and version numbering policies
- Performing configuration audits and status accounting
- Defining tool categorisation: development, verification, production
- Applying IEC 62304 Annex C for software tool validation
- Documenting tool qualification rationale and evidence
- Managing use of commercial off-the-shelf (COTS) tools
- Handling IDEs, compilers, and static analysis tools
- Ensuring test automation tools are validated where required
- Maintaining process documentation for audit readiness
- Aligning document control with ISO 13485 requirements
- Using document templates to ensure consistency
- Establishing review and approval workflows
- Archiving records for regulatory retention periods
- Ensuring readability and reproducibility of digital records
Module 9: Agile and Iterative Development under IEC 62304 - Challenges of applying 62304 to Agile, Scrum, and CI/CD workflows
- Adapting sprint planning to include compliance deliverables
- Embedding traceability in backlog refinement and user stories
- Generating documentation incrementally without lag
- Ensuring each sprint produces verifiable, testable outputs
- Mapping Agile artefacts to IEC 62304 documentation requirements
- Using burndown charts and velocity metrics without compromising traceability
- Conducting sprint retrospectives with compliance insights
- Integrating risk reviews into sprint reviews
- Managing change control in fast-moving development cycles
- Validating continuous integration pipelines for compliance
- Using feature flags and A/B testing responsibly in medical software
- Ensuring audit trails are preserved across automated deployments
- Applying configuration management in Agile environments
- Communicating compliance status in daily stand-ups
- Demonstrating lifecycle compliance to auditors using Agile artefacts
Module 10: Regulatory Submission and Audit Readiness - Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
- Developing a Software Development Plan (SDP) that satisfies clause 5.2
- Defining software configuration items and version control strategy
- Establishing software lifecycle model selection criteria
- Choosing between waterfall, iterative, and agile approaches under 62304
- Integrating software risk classification into early planning
- Defining software coding standards and language restrictions
- Setting up software development environment controls
- Creating a Software Configuration Management Plan (SCMP)
- Developing a Software Problem Resolution Process (SPRP)
- Mapping roles and responsibilities in software teams
- Creating a traceability management strategy from day one
- Defining tools qualification for development and testing environments
- Establishing baseline review points and milestones
- Planning for integration with hardware development timelines
- Documenting assumptions and constraints in the SDP
- Using checklists to validate completeness of planning documents
- Aligning software planning with Design and Development Planning per ISO 13485
- Ensuring independence in verification and validation activities
Module 3: Software Realization Activities – From Requirements to Design - Deriving software requirements from system requirements
- Classifying software requirements: functional, performance, safety
- Writing testable, unambiguous software requirements
- Managing requirement changes with a formal change process
- Creating a Software Requirements Specification (SRS)
- Ensuring SRS traceability to system-level risk analysis
- Using templates for consistent requirement documentation
- Prioritising requirements based on safety classification
- Performing requirement reviews with cross-functional teams
- Identifying incomplete or conflicting requirements early
- Defining inputs for Software Architecture Design (SAD)
- Structuring modular and maintainable software architecture
- Selecting architectural patterns: layered, event-driven, client-server
- Documenting data flow diagrams and control flow
- Allocating requirements to architectural components
- Defining interfaces between software units and external systems
- Addressing concurrency and real-time constraints in design
- Designing for fault tolerance and fail-safe behaviour
- Ensuring security considerations are embedded in design
- Creating a Software Design Description (SDD) that meets auditor expectations
- Incorporating usability and human factors into software design
- Applying design principles: separation of concerns, encapsulation
Module 4: Implementation and Coding Best Practices - Selecting appropriate programming languages for medical software
- Establishing organisational coding standards (e.g. MISRA C, JSF AV)
- Using naming conventions and commenting standards effectively
- Managing global variables and shared resources
- Implementing error handling and exception management
- Avoiding unsafe programming constructs and undefined behaviour
- Ensuring determinism in real-time systems
- Using static analysis tools to detect potential defects
- Integrating code reviews into the development workflow
- Creating unit-level traceability from code to design
- Versioning source code using a defined SCM system
- Managing third-party and open-source software components
- Validating libraries and SDKs for medical use
- Documenting rationale for reuse decisions
- Handling software updates and patches during development
- Applying defensive programming techniques
- Minimising cyclomatic complexity for testability
- Ensuring thread safety in multi-threaded applications
- Using assertions and invariants for self-checking code
- Generating software build records and reproducible builds
Module 5: Software Verification and Testing Strategy - Differentiating verification vs validation in the software context
- Developing a Software Verification Plan (SVP)
- Creating a Software Integration and Testing Plan (SITP)
- Defining entry and exit criteria for each test phase
- Mapping test cases to software requirements and design elements
- Designing black-box and white-box test cases
- Determining appropriate levels of testing: unit, integration, system
- Applying boundary value analysis and equivalence partitioning
- Using state transition testing for complex logic
- Creating test procedures with clear pass/fail criteria
- Executing automated and manual testing in compliance context
- Managing test environments and configuration settings
- Recording test results and deviations systematically
- Handling test failures and initiating problem resolution
- Retesting and regression testing after fixes
- Using code coverage metrics: statement, branch, MC/DC
- Interpreting coverage data for Software Safety Class B and C
- Linking verification results to risk controls
- Preparing for independent review of test evidence
- Using traceability matrices to prove complete verification
Module 6: Software Maintenance and Problem Resolution - Defining the scope of software maintenance under IEC 62304
- Differentiating between corrective, adaptive, perfective, and preventive maintenance
- Establishing a Software Maintenance Plan (SMP)
- Implementing a problem reporting and tracking system
- Classifying severity and urgency of software problems
- Conducting root cause analysis using techniques like 5 Whys or Fishbone
- Documenting problem investigation and resolution rationale
- Assessing impact of changes on software safety classification
- Reapplying verification and validation after changes
- Maintaining configuration baselines during updates
- Tracking field change orders and software version history
- Managing post-market bug fixes and emergency patches
- Ensuring traceability from field reports to code changes
- Updating documentation after maintenance activities
- Preparing for regulatory submissions related to software changes
- Conducting periodic reviews of maintenance effectiveness
- Handling obsolescence of development or runtime environments
- Planning end-of-life for medical software products
Module 7: Software Risk Management Integration - Linking ISO 14971 risk management to IEC 62304 processes
- Identifying software-related hazards and hazardous situations
- Documenting software contribution to overall device risk
- Assigning risk control measures to software functions
- Verifying implementation of software risk controls
- Distinguishing between hardware and software risk mitigation
- Using FMEA for software failure mode analysis
- Applying fault tree analysis (FTA) to software events
- Ensuring risk acceptability is reassessed after changes
- Maintaining risk management file completeness
- Conducting safety architecture reviews
- Documenting safety requirements separately when needed
- Managing residual risk associated with software operation
- Linking risk controls to verification test cases
- Justifying single-fault tolerance in safety-critical code
- Addressing cybersecurity risks as part of safety
- Using safety arguments and claims in regulatory submissions
Module 8: Configuration, Tools, and Process Documentation - Defining software configuration items (SCIs) and their attributes
- Selecting configuration management tools (e.g. Git, SVN, Polarion)
- Establishing branching and merging strategies for compliance
- Creating software build, release, and version numbering policies
- Performing configuration audits and status accounting
- Defining tool categorisation: development, verification, production
- Applying IEC 62304 Annex C for software tool validation
- Documenting tool qualification rationale and evidence
- Managing use of commercial off-the-shelf (COTS) tools
- Handling IDEs, compilers, and static analysis tools
- Ensuring test automation tools are validated where required
- Maintaining process documentation for audit readiness
- Aligning document control with ISO 13485 requirements
- Using document templates to ensure consistency
- Establishing review and approval workflows
- Archiving records for regulatory retention periods
- Ensuring readability and reproducibility of digital records
Module 9: Agile and Iterative Development under IEC 62304 - Challenges of applying 62304 to Agile, Scrum, and CI/CD workflows
- Adapting sprint planning to include compliance deliverables
- Embedding traceability in backlog refinement and user stories
- Generating documentation incrementally without lag
- Ensuring each sprint produces verifiable, testable outputs
- Mapping Agile artefacts to IEC 62304 documentation requirements
- Using burndown charts and velocity metrics without compromising traceability
- Conducting sprint retrospectives with compliance insights
- Integrating risk reviews into sprint reviews
- Managing change control in fast-moving development cycles
- Validating continuous integration pipelines for compliance
- Using feature flags and A/B testing responsibly in medical software
- Ensuring audit trails are preserved across automated deployments
- Applying configuration management in Agile environments
- Communicating compliance status in daily stand-ups
- Demonstrating lifecycle compliance to auditors using Agile artefacts
Module 10: Regulatory Submission and Audit Readiness - Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
- Selecting appropriate programming languages for medical software
- Establishing organisational coding standards (e.g. MISRA C, JSF AV)
- Using naming conventions and commenting standards effectively
- Managing global variables and shared resources
- Implementing error handling and exception management
- Avoiding unsafe programming constructs and undefined behaviour
- Ensuring determinism in real-time systems
- Using static analysis tools to detect potential defects
- Integrating code reviews into the development workflow
- Creating unit-level traceability from code to design
- Versioning source code using a defined SCM system
- Managing third-party and open-source software components
- Validating libraries and SDKs for medical use
- Documenting rationale for reuse decisions
- Handling software updates and patches during development
- Applying defensive programming techniques
- Minimising cyclomatic complexity for testability
- Ensuring thread safety in multi-threaded applications
- Using assertions and invariants for self-checking code
- Generating software build records and reproducible builds
Module 5: Software Verification and Testing Strategy - Differentiating verification vs validation in the software context
- Developing a Software Verification Plan (SVP)
- Creating a Software Integration and Testing Plan (SITP)
- Defining entry and exit criteria for each test phase
- Mapping test cases to software requirements and design elements
- Designing black-box and white-box test cases
- Determining appropriate levels of testing: unit, integration, system
- Applying boundary value analysis and equivalence partitioning
- Using state transition testing for complex logic
- Creating test procedures with clear pass/fail criteria
- Executing automated and manual testing in compliance context
- Managing test environments and configuration settings
- Recording test results and deviations systematically
- Handling test failures and initiating problem resolution
- Retesting and regression testing after fixes
- Using code coverage metrics: statement, branch, MC/DC
- Interpreting coverage data for Software Safety Class B and C
- Linking verification results to risk controls
- Preparing for independent review of test evidence
- Using traceability matrices to prove complete verification
Module 6: Software Maintenance and Problem Resolution - Defining the scope of software maintenance under IEC 62304
- Differentiating between corrective, adaptive, perfective, and preventive maintenance
- Establishing a Software Maintenance Plan (SMP)
- Implementing a problem reporting and tracking system
- Classifying severity and urgency of software problems
- Conducting root cause analysis using techniques like 5 Whys or Fishbone
- Documenting problem investigation and resolution rationale
- Assessing impact of changes on software safety classification
- Reapplying verification and validation after changes
- Maintaining configuration baselines during updates
- Tracking field change orders and software version history
- Managing post-market bug fixes and emergency patches
- Ensuring traceability from field reports to code changes
- Updating documentation after maintenance activities
- Preparing for regulatory submissions related to software changes
- Conducting periodic reviews of maintenance effectiveness
- Handling obsolescence of development or runtime environments
- Planning end-of-life for medical software products
Module 7: Software Risk Management Integration - Linking ISO 14971 risk management to IEC 62304 processes
- Identifying software-related hazards and hazardous situations
- Documenting software contribution to overall device risk
- Assigning risk control measures to software functions
- Verifying implementation of software risk controls
- Distinguishing between hardware and software risk mitigation
- Using FMEA for software failure mode analysis
- Applying fault tree analysis (FTA) to software events
- Ensuring risk acceptability is reassessed after changes
- Maintaining risk management file completeness
- Conducting safety architecture reviews
- Documenting safety requirements separately when needed
- Managing residual risk associated with software operation
- Linking risk controls to verification test cases
- Justifying single-fault tolerance in safety-critical code
- Addressing cybersecurity risks as part of safety
- Using safety arguments and claims in regulatory submissions
Module 8: Configuration, Tools, and Process Documentation - Defining software configuration items (SCIs) and their attributes
- Selecting configuration management tools (e.g. Git, SVN, Polarion)
- Establishing branching and merging strategies for compliance
- Creating software build, release, and version numbering policies
- Performing configuration audits and status accounting
- Defining tool categorisation: development, verification, production
- Applying IEC 62304 Annex C for software tool validation
- Documenting tool qualification rationale and evidence
- Managing use of commercial off-the-shelf (COTS) tools
- Handling IDEs, compilers, and static analysis tools
- Ensuring test automation tools are validated where required
- Maintaining process documentation for audit readiness
- Aligning document control with ISO 13485 requirements
- Using document templates to ensure consistency
- Establishing review and approval workflows
- Archiving records for regulatory retention periods
- Ensuring readability and reproducibility of digital records
Module 9: Agile and Iterative Development under IEC 62304 - Challenges of applying 62304 to Agile, Scrum, and CI/CD workflows
- Adapting sprint planning to include compliance deliverables
- Embedding traceability in backlog refinement and user stories
- Generating documentation incrementally without lag
- Ensuring each sprint produces verifiable, testable outputs
- Mapping Agile artefacts to IEC 62304 documentation requirements
- Using burndown charts and velocity metrics without compromising traceability
- Conducting sprint retrospectives with compliance insights
- Integrating risk reviews into sprint reviews
- Managing change control in fast-moving development cycles
- Validating continuous integration pipelines for compliance
- Using feature flags and A/B testing responsibly in medical software
- Ensuring audit trails are preserved across automated deployments
- Applying configuration management in Agile environments
- Communicating compliance status in daily stand-ups
- Demonstrating lifecycle compliance to auditors using Agile artefacts
Module 10: Regulatory Submission and Audit Readiness - Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
- Defining the scope of software maintenance under IEC 62304
- Differentiating between corrective, adaptive, perfective, and preventive maintenance
- Establishing a Software Maintenance Plan (SMP)
- Implementing a problem reporting and tracking system
- Classifying severity and urgency of software problems
- Conducting root cause analysis using techniques like 5 Whys or Fishbone
- Documenting problem investigation and resolution rationale
- Assessing impact of changes on software safety classification
- Reapplying verification and validation after changes
- Maintaining configuration baselines during updates
- Tracking field change orders and software version history
- Managing post-market bug fixes and emergency patches
- Ensuring traceability from field reports to code changes
- Updating documentation after maintenance activities
- Preparing for regulatory submissions related to software changes
- Conducting periodic reviews of maintenance effectiveness
- Handling obsolescence of development or runtime environments
- Planning end-of-life for medical software products
Module 7: Software Risk Management Integration - Linking ISO 14971 risk management to IEC 62304 processes
- Identifying software-related hazards and hazardous situations
- Documenting software contribution to overall device risk
- Assigning risk control measures to software functions
- Verifying implementation of software risk controls
- Distinguishing between hardware and software risk mitigation
- Using FMEA for software failure mode analysis
- Applying fault tree analysis (FTA) to software events
- Ensuring risk acceptability is reassessed after changes
- Maintaining risk management file completeness
- Conducting safety architecture reviews
- Documenting safety requirements separately when needed
- Managing residual risk associated with software operation
- Linking risk controls to verification test cases
- Justifying single-fault tolerance in safety-critical code
- Addressing cybersecurity risks as part of safety
- Using safety arguments and claims in regulatory submissions
Module 8: Configuration, Tools, and Process Documentation - Defining software configuration items (SCIs) and their attributes
- Selecting configuration management tools (e.g. Git, SVN, Polarion)
- Establishing branching and merging strategies for compliance
- Creating software build, release, and version numbering policies
- Performing configuration audits and status accounting
- Defining tool categorisation: development, verification, production
- Applying IEC 62304 Annex C for software tool validation
- Documenting tool qualification rationale and evidence
- Managing use of commercial off-the-shelf (COTS) tools
- Handling IDEs, compilers, and static analysis tools
- Ensuring test automation tools are validated where required
- Maintaining process documentation for audit readiness
- Aligning document control with ISO 13485 requirements
- Using document templates to ensure consistency
- Establishing review and approval workflows
- Archiving records for regulatory retention periods
- Ensuring readability and reproducibility of digital records
Module 9: Agile and Iterative Development under IEC 62304 - Challenges of applying 62304 to Agile, Scrum, and CI/CD workflows
- Adapting sprint planning to include compliance deliverables
- Embedding traceability in backlog refinement and user stories
- Generating documentation incrementally without lag
- Ensuring each sprint produces verifiable, testable outputs
- Mapping Agile artefacts to IEC 62304 documentation requirements
- Using burndown charts and velocity metrics without compromising traceability
- Conducting sprint retrospectives with compliance insights
- Integrating risk reviews into sprint reviews
- Managing change control in fast-moving development cycles
- Validating continuous integration pipelines for compliance
- Using feature flags and A/B testing responsibly in medical software
- Ensuring audit trails are preserved across automated deployments
- Applying configuration management in Agile environments
- Communicating compliance status in daily stand-ups
- Demonstrating lifecycle compliance to auditors using Agile artefacts
Module 10: Regulatory Submission and Audit Readiness - Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
- Defining software configuration items (SCIs) and their attributes
- Selecting configuration management tools (e.g. Git, SVN, Polarion)
- Establishing branching and merging strategies for compliance
- Creating software build, release, and version numbering policies
- Performing configuration audits and status accounting
- Defining tool categorisation: development, verification, production
- Applying IEC 62304 Annex C for software tool validation
- Documenting tool qualification rationale and evidence
- Managing use of commercial off-the-shelf (COTS) tools
- Handling IDEs, compilers, and static analysis tools
- Ensuring test automation tools are validated where required
- Maintaining process documentation for audit readiness
- Aligning document control with ISO 13485 requirements
- Using document templates to ensure consistency
- Establishing review and approval workflows
- Archiving records for regulatory retention periods
- Ensuring readability and reproducibility of digital records
Module 9: Agile and Iterative Development under IEC 62304 - Challenges of applying 62304 to Agile, Scrum, and CI/CD workflows
- Adapting sprint planning to include compliance deliverables
- Embedding traceability in backlog refinement and user stories
- Generating documentation incrementally without lag
- Ensuring each sprint produces verifiable, testable outputs
- Mapping Agile artefacts to IEC 62304 documentation requirements
- Using burndown charts and velocity metrics without compromising traceability
- Conducting sprint retrospectives with compliance insights
- Integrating risk reviews into sprint reviews
- Managing change control in fast-moving development cycles
- Validating continuous integration pipelines for compliance
- Using feature flags and A/B testing responsibly in medical software
- Ensuring audit trails are preserved across automated deployments
- Applying configuration management in Agile environments
- Communicating compliance status in daily stand-ups
- Demonstrating lifecycle compliance to auditors using Agile artefacts
Module 10: Regulatory Submission and Audit Readiness - Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
- Preparing a software section for FDA premarket submissions (510k, PMA)
- Structuring software documentation for Notified Body review under MDR
- Creating a Software of Unknown Provenance (SOUP) assessment
- Compiling the Software Life Cycle Requirements Specification (SLRS)
- Developing the Software Design Description (SDD) for regulators
- Providing summary of verification and validation results
- Presenting traceability matrices in auditor-friendly format
- Using summary reports to condense large volumes of evidence
- Responding to deficiency letters related to software compliance
- Preparing for surveillance and pre-certification audits
- Training internal teams to handle auditor questions
- Anticipating common audit findings and how to prevent them
- Organising documentation using a virtual auditor room structure
- Practicing mock audits with realistic scenarios
- Ensuring all signatures and approvals are current
- Using checklists to validate submission completeness
- Demonstrating ongoing compliance beyond initial clearance
Module 11: Advanced Topics and Special Cases - Handling software as a medical device (SaMD) under 62304
- Managing AI/ML-based algorithms in regulated software
- Applying 62304 to mobile medical apps and cloud-based platforms
- Complying with cybersecurity requirements from IEC 81001-5-1
- Addressing data privacy regulations (GDPR, HIPAA) in design
- Managing updates and patches in connected devices
- Ensuring over-the-air (OTA) updates are controlled and validated
- Handling machine learning model drift and retraining
- Validating inference engines and probabilistic outputs
- Dealing with third-party APIs and cloud services
- Designing for multi-centre clinical data integration
- Ensuring interoperability without sacrificing safety
- Managing containerised software (e.g. Docker, Kubernetes)
- Addressing virtualisation in medical software deployments
- Handling real-time data streaming and edge computing
- Designing failover and redundancy mechanisms
Module 12: Certification, Career Growth, and Next Steps - Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time
- Reviewing all course modules for final assessment
- Completing the final compliance project: Build a regulator-ready SDP
- Submitting work for instructor review and feedback
- Receiving your Certificate of Completion from The Art of Service
- Adding the credential to your LinkedIn profile and resume
- Using the certificate to support internal promotions or job applications
- Accessing alumni resources and update notifications
- Joining the global network of IEC 62304 practitioners
- Identifying next-level certifications (e.g. CQA, CSE, RAC)
- Building a personal compliance playbook for future projects
- Creating a reusable template library for your organisation
- Establishing yourself as the go-to compliance expert
- Transitioning from implementer to leader in software quality
- Presenting your achievement to management and stakeholders
- Tracking your progress with built-in learning milestones
- Accessing gamified achievement badges for motivation
- Setting goals for long-term professional development
- Leveraging the course content as a living reference guide
- Updating your playbook with future regulatory changes
- Continuously improving your compliance maturity over time