ISO 14971 A Complete Guide
You’re under pressure. Regulatory deadlines loom, product requirements are tightening, and your team is relying on you to ensure that every medical device risk is properly assessed, documented, and justifiable. One misstep could cost your organisation millions - or worse, patient safety. Uncertainty around ISO 14971 is no longer a small compliance gap. It’s a strategic liability. Without complete mastery of risk management principles from concept to post-market surveillance, your product approvals stall, your audits fail, and your career momentum stalls with them. But what if you had a step-by-step blueprint - not just to understand ISO 14971, but to apply it confidently across your organisation, streamline your documentation, and lead your team with authority? The ISO 14971 A Complete Guide is that blueprint. This course transforms you from someone who fears risk documentation into the recognised expert who owns it. In as little as 15 hours, you’ll go from uncertain to board-ready, producing audit-proof risk files, leading design reviews with confidence, and creating living risk management files that evolve with your product lifecycle. Take Sarah M., Principal Risk Analyst at a Class III device manufacturer in Germany. After completing this course, she led her company through a successful EU MDR audit - the notified body specifically praised their risk management file. Her team now uses her updated templates enterprise-wide. She earned a promotion two months later. No more guessing, no more patchwork learning. Here’s how this course is structured to help you get there.Self-Paced. Always Updated. 100% Focused on Your Confidence and Results. ISO 14971 A Complete Guide is designed for professionals like you - engineers, QA managers, regulatory specialists, and clinical leads - who need precision, clarity, and speed without sacrificing depth. This is not theory. This is the exact system used by top-performing medical device organisations to pass audits and accelerate approvals. What You Get - and Why It Removes Risk
Immediate online access. Enrol today and begin immediately. No waiting for enrolment windows or onboarding calls. This is a fully self-paced course, with on-demand learning built for global schedules and complex workloads. Designed for real-world professionals, most learners complete the core content in 12 to 15 hours - many applying what they learn within days to ongoing projects, risk assessments, and documentation tasks. You’ll see tangible progress by the end of Module 2. Lifetime access, full updates included. Standards evolve. Your knowledge must too. You’ll receive all future updates to this course at no additional cost, ensuring your expertise remains current with any revisions to ISO 14971 or related regulatory expectations. Access your materials 24/7 from any device. The course platform is fully mobile-friendly, so you can review content during travel, between meetings, or from your lab station. Expertise You Can Trust - With Real Support
You’re not alone. Your learning journey includes direct access to our course support team - experienced ISO 14971 practitioners with years of real-world risk management experience in Class II and Class III device environments. If you have a question about risk-benefit analysis, post-market surveillance integration, or how to justify a residual risk decision to your notified body, help is available. This isn’t an automated chatbot - it’s human support from people who have faced the same regulatory scrutiny you’re under. Certification That Carries Weight
Upon successful completion, you’ll earn a Certificate of Completion issued by The Art of Service - a globally recognised credential trusted by regulatory professionals in over 120 countries. This isn’t a participation trophy. It verifies that you’ve mastered ISO 14971 in full alignment with international regulatory expectations, including EU MDR, FDA Quality System Regulation, and harmonised standards like ISO 13485. No Hidden Costs. No Risk. Full Transparency.
The pricing is straightforward. There are no hidden fees, no subscription traps, and no surprise charges. What you see is exactly what you get - one clear investment for lifetime value. We accept all major payment methods, including Visa, Mastercard, and PayPal. Transactions are secure, encrypted, and processed instantly. Still wondering, “Will this work for me?” Consider this: Our learners come from every role involved in medical device development. Engineers. Regulatory Affairs Managers. QA/QC Leads. Clinical Evaluation Specialists. Even Notified Body Auditors who use this course to sharpen their assessment skills. - If you’ve struggled to align your risk management file with design controls, this course works.
- If you’ve been told your risk analysis lacks depth or traceability, this course works.
- If you’ve ever frozen during an audit when asked to explain your risk mitigation logic, this course works.
This works even if: You're not a full-time risk manager, your company uses different templates, your device is software as a medical device (SaMD), or you're preparing for your first MDR submission. Our Ironclad Guarantee
We eliminate your risk with a rock-solid promise: If after completing the course you don’t feel dramatically more confident in applying ISO 14971 - if you wouldn’t recommend it without hesitation - contact us for a full refund. No questions, no hoops. After enrollment, you’ll receive a confirmation email with instructions. Your course access details will be sent separately once your registration is fully processed and your materials are ready - ensuring you receive a polished, verified learning experience. This is your career. Your reputation. Your product’s compliance. Let’s build it on certainty - not guesswork.
Module 1: Foundations of Medical Device Risk Management - Understanding the global regulatory landscape for medical device safety
- The evolution and purpose of ISO 14971: from 2007 to current revisions
- How ISO 14971 integrates with ISO 13485 and EU MDR Article 10
- Key definitions: hazard, hazardous situation, harm, risk, risk control, residual risk
- The role of risk management in the medical device lifecycle
- Differences between risk management for software, mechanical, and combination devices
- Overview of the risk management process and its integration with design and development
- Understanding the scope and applicability of the standard to different device classes
- Responsibility of top management in supporting risk management activities
- Creating a risk management policy aligned with company culture and compliance goals
Module 2: Risk Management Frameworks and Process Overview - Step-by-step breakdown of the ISO 14971 risk management process
- Establishing a risk management plan: structure, ownership, and deliverables
- Defining project-specific risk management roles and responsibilities
- Developing acceptance criteria for risk based on severity and probability
- Linking risk management to product development phases
- Integration with Design and Development planning per ISO 13485
- Documentation requirements: what auditors expect to see
- Creating a risk management file structure from the beginning
- How to maintain traceability across design inputs, outputs, and validation
- Version control and revision management for risk documents
Module 3: Risk Analysis – Identifying Hazards and Scenarios - What constitutes a hazard under ISO 14971
- Techniques for comprehensive hazard identification
- Using brainstorming, HAZOP, and use error analysis effectively
- Incorporating user, patient, and environmental factors in hazard identification
- Differentiating between intrinsic hazards and misuse scenarios
- How to document foreseeable misuse without overcomplicating risk files
- Linking hazards to intended use and device functions
- Using failure mode analysis to anticipate device behaviour under stress
- Identifying hazards related to software functions and connectivity
- Handling hazards from accessories, interfaces, and third-party components
- Supplier input in hazard identification for outsourced components
- Leveraging post-market feedback to enrich hazard analysis
- Tools for structuring hazard analysis in complex systems
- Creating a comprehensive hazard registry
- When to involve clinical and human factors experts in hazard identification
Module 4: Risk Estimation – Probability, Severity, and Risk Evaluation - Understanding severity levels: minor, critical, catastrophic
- Estimating probability of occurrence: qualitative vs quantitative methods
- Building a risk matrix aligned with ISO 14971 principles
- Justifying probability ratings with clinical and engineering data
- How to assess combination risks without double-counting
- Different approaches to risk ranking: matrices, scales, and scoring systems
- Acceptable risk thresholds: defining your risk criteria
- When to escalate risk for management review
- Documentation required for risk estimation in an audit context
- Using historical failure data to inform risk likelihood estimates
- Addressing rare but high-consequence events
- Working with cross-functional teams to validate risk estimates
- Aligning risk estimation practices with stakeholder expectations
- Managing subjectivity in risk assessment through checks and balances
- Creating traceable decision logs for risk evaluation
Module 5: Risk Control – Applying the Hierarchy of Controls - The three-tiers of risk control: inherent safety, protective measures, information for safety
- Designing out hazards at the source: strategies for elimination
- Implementing passive and active protective mechanisms
- Effectiveness rating of risk control measures
- How to verify and validate risk controls post-implementation
- Linking risk controls to design outputs and specifications
- Using engineering prototypes to test risk control efficacy
- When to involve manufacturing in risk control execution
- Software-based risk controls: monitoring, alarms, locks
- Labelling, IFU, and training as the last line of defence
- Justifying reliance on information for safety
- Addressing residual risk due to control limitations
- Ensuring risk control integration across hardware, software, and packaging
- Verification testing specifically for risk control validation
- Failure of risk controls: what happens when protections fail
Module 6: Risk Evaluation After Risk Control - Performing residual risk assessment for each hazard-scenario pair
- Re-evaluating risk using the same criteria as initial estimation
- Determining if residual risk is acceptable for patient and user
- Justifying acceptance of residual risk with clinical benefit analysis
- Required documentation: residual risk analysis and review records
- When to require additional risk controls despite initial acceptance
- Managing risks with high severity even at low probability
- Role of clinical experts in reviewing residual risk determinations
- Auditors’ expectations when reviewing residual risk files
- Presenting residual risk conclusions to notified bodies
- Updating risk evaluation as new data becomes available
- Using traceability matrices to link controls to residual evaluations
- Handling incomplete risk control implementation during development
- Creating a risk-benefit analysis for high-profile risks
- Risk evaluation integration with clinical evaluation reports
Module 7: Overall Risk Evaluation and Management Review - Conducting an overall risk evaluation for the entire device
- Aggregating residual risks into a unified safety profile
- Balancing cumulative risk across all device functions
- Producing a summary statement of safety and clinical benefit
- Aligning with EU MDR requirements for benefit-risk determination
- Management’s role in reviewing and approving overall risk decisions
- Documenting formal management review of risk outcomes
- Ensuring alignment between risk evaluation and product launch decisions
- Leveraging risk evaluation in market access and reimbursement strategies
- Preparing for regulatory scrutiny of your overall risk justification
- Using visual dashboards to communicate overall risk posture
- Managing stakeholder concerns during overall risk review
- Updating overall risk evaluation during post-market phases
- Linking overall risk conclusions to labelling and marketing claims
- Creating an executive summary for non-technical decision-makers
Module 8: Risk Management File – Structure, Content, and Audit Readiness - Essential components of a complete risk management file
- How to structure documents for regulatory inspection efficiency
- Ensuring traceability from hazard to control to residual risk
- Linking risk management file to design history file
- Versioning, indexing, and organisation best practices
- What auditors look for in a risk management file review
- Common audit findings and how to avoid them
- Preparing for unannounced audits with a living risk file
- Using cross-references to support compliance documentation
- Creating a risk management report per ISO 14971 Clause 7.4
- Integrating risk information into technical documentation
- Handling modifications to the risk management file during device lifecycle
- Best practices for electronic records and e-signatures
- Searchability, navigation, and document control in digital files
- Standardising templates across product lines
Module 9: Production and Post-Production Activities - Transferring risk management output to production environments
- Ensuring manufacturing processes don't introduce new risks
- Monitoring for non-conformities that affect risk profile
- Integrating risk management into corrective and preventive actions (CAPA)
- How post-market surveillance feeds back into risk assessment
- Using customer complaints to trigger risk reassessment
- Updating risk files based on field reports and adverse events
- Linking post-market data to periodic risk evaluation updates
- Role of risk management in field safety corrective actions (FSCA)
- Integrating risk into post-market clinical follow-up (PMCF)
- Responding to emerging risks from real-world evidence
- Updating risk-benefit analysis based on population-level data
- Reporting updated risk assessments to notified bodies when required
- Managing risk during product modifications and upgrades
- Creating a closed-loop risk management system
Module 10: Integration with Human Factors and Usability Engineering - Linking risk management to IEC 62366 usability engineering
- Using use error analysis as a hazard identification tool
- Differentiating between use errors and device malfunctions
- Designing risk controls based on user interaction findings
- Aligning user profiles with risk scenarios
- Integrating usability test results into risk estimation
- How to mitigate risks arising from poor human-device interaction
- Using formative and summative testing data for risk validation
- Addressing high-risk use scenarios identified in testing
- Documenting risk considerations in usability engineering files
- Justifying risk controls related to user training and instructions
- Aligning risk and usability timelines during development
- Reporting usability-related risks to regulatory bodies
- Handling off-label use in risk and usability assessments
- Creating seamless integration between risk and usability teams
Module 11: Software as a Medical Device and Cybersecurity Risk - Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- Understanding the global regulatory landscape for medical device safety
- The evolution and purpose of ISO 14971: from 2007 to current revisions
- How ISO 14971 integrates with ISO 13485 and EU MDR Article 10
- Key definitions: hazard, hazardous situation, harm, risk, risk control, residual risk
- The role of risk management in the medical device lifecycle
- Differences between risk management for software, mechanical, and combination devices
- Overview of the risk management process and its integration with design and development
- Understanding the scope and applicability of the standard to different device classes
- Responsibility of top management in supporting risk management activities
- Creating a risk management policy aligned with company culture and compliance goals
Module 2: Risk Management Frameworks and Process Overview - Step-by-step breakdown of the ISO 14971 risk management process
- Establishing a risk management plan: structure, ownership, and deliverables
- Defining project-specific risk management roles and responsibilities
- Developing acceptance criteria for risk based on severity and probability
- Linking risk management to product development phases
- Integration with Design and Development planning per ISO 13485
- Documentation requirements: what auditors expect to see
- Creating a risk management file structure from the beginning
- How to maintain traceability across design inputs, outputs, and validation
- Version control and revision management for risk documents
Module 3: Risk Analysis – Identifying Hazards and Scenarios - What constitutes a hazard under ISO 14971
- Techniques for comprehensive hazard identification
- Using brainstorming, HAZOP, and use error analysis effectively
- Incorporating user, patient, and environmental factors in hazard identification
- Differentiating between intrinsic hazards and misuse scenarios
- How to document foreseeable misuse without overcomplicating risk files
- Linking hazards to intended use and device functions
- Using failure mode analysis to anticipate device behaviour under stress
- Identifying hazards related to software functions and connectivity
- Handling hazards from accessories, interfaces, and third-party components
- Supplier input in hazard identification for outsourced components
- Leveraging post-market feedback to enrich hazard analysis
- Tools for structuring hazard analysis in complex systems
- Creating a comprehensive hazard registry
- When to involve clinical and human factors experts in hazard identification
Module 4: Risk Estimation – Probability, Severity, and Risk Evaluation - Understanding severity levels: minor, critical, catastrophic
- Estimating probability of occurrence: qualitative vs quantitative methods
- Building a risk matrix aligned with ISO 14971 principles
- Justifying probability ratings with clinical and engineering data
- How to assess combination risks without double-counting
- Different approaches to risk ranking: matrices, scales, and scoring systems
- Acceptable risk thresholds: defining your risk criteria
- When to escalate risk for management review
- Documentation required for risk estimation in an audit context
- Using historical failure data to inform risk likelihood estimates
- Addressing rare but high-consequence events
- Working with cross-functional teams to validate risk estimates
- Aligning risk estimation practices with stakeholder expectations
- Managing subjectivity in risk assessment through checks and balances
- Creating traceable decision logs for risk evaluation
Module 5: Risk Control – Applying the Hierarchy of Controls - The three-tiers of risk control: inherent safety, protective measures, information for safety
- Designing out hazards at the source: strategies for elimination
- Implementing passive and active protective mechanisms
- Effectiveness rating of risk control measures
- How to verify and validate risk controls post-implementation
- Linking risk controls to design outputs and specifications
- Using engineering prototypes to test risk control efficacy
- When to involve manufacturing in risk control execution
- Software-based risk controls: monitoring, alarms, locks
- Labelling, IFU, and training as the last line of defence
- Justifying reliance on information for safety
- Addressing residual risk due to control limitations
- Ensuring risk control integration across hardware, software, and packaging
- Verification testing specifically for risk control validation
- Failure of risk controls: what happens when protections fail
Module 6: Risk Evaluation After Risk Control - Performing residual risk assessment for each hazard-scenario pair
- Re-evaluating risk using the same criteria as initial estimation
- Determining if residual risk is acceptable for patient and user
- Justifying acceptance of residual risk with clinical benefit analysis
- Required documentation: residual risk analysis and review records
- When to require additional risk controls despite initial acceptance
- Managing risks with high severity even at low probability
- Role of clinical experts in reviewing residual risk determinations
- Auditors’ expectations when reviewing residual risk files
- Presenting residual risk conclusions to notified bodies
- Updating risk evaluation as new data becomes available
- Using traceability matrices to link controls to residual evaluations
- Handling incomplete risk control implementation during development
- Creating a risk-benefit analysis for high-profile risks
- Risk evaluation integration with clinical evaluation reports
Module 7: Overall Risk Evaluation and Management Review - Conducting an overall risk evaluation for the entire device
- Aggregating residual risks into a unified safety profile
- Balancing cumulative risk across all device functions
- Producing a summary statement of safety and clinical benefit
- Aligning with EU MDR requirements for benefit-risk determination
- Management’s role in reviewing and approving overall risk decisions
- Documenting formal management review of risk outcomes
- Ensuring alignment between risk evaluation and product launch decisions
- Leveraging risk evaluation in market access and reimbursement strategies
- Preparing for regulatory scrutiny of your overall risk justification
- Using visual dashboards to communicate overall risk posture
- Managing stakeholder concerns during overall risk review
- Updating overall risk evaluation during post-market phases
- Linking overall risk conclusions to labelling and marketing claims
- Creating an executive summary for non-technical decision-makers
Module 8: Risk Management File – Structure, Content, and Audit Readiness - Essential components of a complete risk management file
- How to structure documents for regulatory inspection efficiency
- Ensuring traceability from hazard to control to residual risk
- Linking risk management file to design history file
- Versioning, indexing, and organisation best practices
- What auditors look for in a risk management file review
- Common audit findings and how to avoid them
- Preparing for unannounced audits with a living risk file
- Using cross-references to support compliance documentation
- Creating a risk management report per ISO 14971 Clause 7.4
- Integrating risk information into technical documentation
- Handling modifications to the risk management file during device lifecycle
- Best practices for electronic records and e-signatures
- Searchability, navigation, and document control in digital files
- Standardising templates across product lines
Module 9: Production and Post-Production Activities - Transferring risk management output to production environments
- Ensuring manufacturing processes don't introduce new risks
- Monitoring for non-conformities that affect risk profile
- Integrating risk management into corrective and preventive actions (CAPA)
- How post-market surveillance feeds back into risk assessment
- Using customer complaints to trigger risk reassessment
- Updating risk files based on field reports and adverse events
- Linking post-market data to periodic risk evaluation updates
- Role of risk management in field safety corrective actions (FSCA)
- Integrating risk into post-market clinical follow-up (PMCF)
- Responding to emerging risks from real-world evidence
- Updating risk-benefit analysis based on population-level data
- Reporting updated risk assessments to notified bodies when required
- Managing risk during product modifications and upgrades
- Creating a closed-loop risk management system
Module 10: Integration with Human Factors and Usability Engineering - Linking risk management to IEC 62366 usability engineering
- Using use error analysis as a hazard identification tool
- Differentiating between use errors and device malfunctions
- Designing risk controls based on user interaction findings
- Aligning user profiles with risk scenarios
- Integrating usability test results into risk estimation
- How to mitigate risks arising from poor human-device interaction
- Using formative and summative testing data for risk validation
- Addressing high-risk use scenarios identified in testing
- Documenting risk considerations in usability engineering files
- Justifying risk controls related to user training and instructions
- Aligning risk and usability timelines during development
- Reporting usability-related risks to regulatory bodies
- Handling off-label use in risk and usability assessments
- Creating seamless integration between risk and usability teams
Module 11: Software as a Medical Device and Cybersecurity Risk - Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- What constitutes a hazard under ISO 14971
- Techniques for comprehensive hazard identification
- Using brainstorming, HAZOP, and use error analysis effectively
- Incorporating user, patient, and environmental factors in hazard identification
- Differentiating between intrinsic hazards and misuse scenarios
- How to document foreseeable misuse without overcomplicating risk files
- Linking hazards to intended use and device functions
- Using failure mode analysis to anticipate device behaviour under stress
- Identifying hazards related to software functions and connectivity
- Handling hazards from accessories, interfaces, and third-party components
- Supplier input in hazard identification for outsourced components
- Leveraging post-market feedback to enrich hazard analysis
- Tools for structuring hazard analysis in complex systems
- Creating a comprehensive hazard registry
- When to involve clinical and human factors experts in hazard identification
Module 4: Risk Estimation – Probability, Severity, and Risk Evaluation - Understanding severity levels: minor, critical, catastrophic
- Estimating probability of occurrence: qualitative vs quantitative methods
- Building a risk matrix aligned with ISO 14971 principles
- Justifying probability ratings with clinical and engineering data
- How to assess combination risks without double-counting
- Different approaches to risk ranking: matrices, scales, and scoring systems
- Acceptable risk thresholds: defining your risk criteria
- When to escalate risk for management review
- Documentation required for risk estimation in an audit context
- Using historical failure data to inform risk likelihood estimates
- Addressing rare but high-consequence events
- Working with cross-functional teams to validate risk estimates
- Aligning risk estimation practices with stakeholder expectations
- Managing subjectivity in risk assessment through checks and balances
- Creating traceable decision logs for risk evaluation
Module 5: Risk Control – Applying the Hierarchy of Controls - The three-tiers of risk control: inherent safety, protective measures, information for safety
- Designing out hazards at the source: strategies for elimination
- Implementing passive and active protective mechanisms
- Effectiveness rating of risk control measures
- How to verify and validate risk controls post-implementation
- Linking risk controls to design outputs and specifications
- Using engineering prototypes to test risk control efficacy
- When to involve manufacturing in risk control execution
- Software-based risk controls: monitoring, alarms, locks
- Labelling, IFU, and training as the last line of defence
- Justifying reliance on information for safety
- Addressing residual risk due to control limitations
- Ensuring risk control integration across hardware, software, and packaging
- Verification testing specifically for risk control validation
- Failure of risk controls: what happens when protections fail
Module 6: Risk Evaluation After Risk Control - Performing residual risk assessment for each hazard-scenario pair
- Re-evaluating risk using the same criteria as initial estimation
- Determining if residual risk is acceptable for patient and user
- Justifying acceptance of residual risk with clinical benefit analysis
- Required documentation: residual risk analysis and review records
- When to require additional risk controls despite initial acceptance
- Managing risks with high severity even at low probability
- Role of clinical experts in reviewing residual risk determinations
- Auditors’ expectations when reviewing residual risk files
- Presenting residual risk conclusions to notified bodies
- Updating risk evaluation as new data becomes available
- Using traceability matrices to link controls to residual evaluations
- Handling incomplete risk control implementation during development
- Creating a risk-benefit analysis for high-profile risks
- Risk evaluation integration with clinical evaluation reports
Module 7: Overall Risk Evaluation and Management Review - Conducting an overall risk evaluation for the entire device
- Aggregating residual risks into a unified safety profile
- Balancing cumulative risk across all device functions
- Producing a summary statement of safety and clinical benefit
- Aligning with EU MDR requirements for benefit-risk determination
- Management’s role in reviewing and approving overall risk decisions
- Documenting formal management review of risk outcomes
- Ensuring alignment between risk evaluation and product launch decisions
- Leveraging risk evaluation in market access and reimbursement strategies
- Preparing for regulatory scrutiny of your overall risk justification
- Using visual dashboards to communicate overall risk posture
- Managing stakeholder concerns during overall risk review
- Updating overall risk evaluation during post-market phases
- Linking overall risk conclusions to labelling and marketing claims
- Creating an executive summary for non-technical decision-makers
Module 8: Risk Management File – Structure, Content, and Audit Readiness - Essential components of a complete risk management file
- How to structure documents for regulatory inspection efficiency
- Ensuring traceability from hazard to control to residual risk
- Linking risk management file to design history file
- Versioning, indexing, and organisation best practices
- What auditors look for in a risk management file review
- Common audit findings and how to avoid them
- Preparing for unannounced audits with a living risk file
- Using cross-references to support compliance documentation
- Creating a risk management report per ISO 14971 Clause 7.4
- Integrating risk information into technical documentation
- Handling modifications to the risk management file during device lifecycle
- Best practices for electronic records and e-signatures
- Searchability, navigation, and document control in digital files
- Standardising templates across product lines
Module 9: Production and Post-Production Activities - Transferring risk management output to production environments
- Ensuring manufacturing processes don't introduce new risks
- Monitoring for non-conformities that affect risk profile
- Integrating risk management into corrective and preventive actions (CAPA)
- How post-market surveillance feeds back into risk assessment
- Using customer complaints to trigger risk reassessment
- Updating risk files based on field reports and adverse events
- Linking post-market data to periodic risk evaluation updates
- Role of risk management in field safety corrective actions (FSCA)
- Integrating risk into post-market clinical follow-up (PMCF)
- Responding to emerging risks from real-world evidence
- Updating risk-benefit analysis based on population-level data
- Reporting updated risk assessments to notified bodies when required
- Managing risk during product modifications and upgrades
- Creating a closed-loop risk management system
Module 10: Integration with Human Factors and Usability Engineering - Linking risk management to IEC 62366 usability engineering
- Using use error analysis as a hazard identification tool
- Differentiating between use errors and device malfunctions
- Designing risk controls based on user interaction findings
- Aligning user profiles with risk scenarios
- Integrating usability test results into risk estimation
- How to mitigate risks arising from poor human-device interaction
- Using formative and summative testing data for risk validation
- Addressing high-risk use scenarios identified in testing
- Documenting risk considerations in usability engineering files
- Justifying risk controls related to user training and instructions
- Aligning risk and usability timelines during development
- Reporting usability-related risks to regulatory bodies
- Handling off-label use in risk and usability assessments
- Creating seamless integration between risk and usability teams
Module 11: Software as a Medical Device and Cybersecurity Risk - Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- The three-tiers of risk control: inherent safety, protective measures, information for safety
- Designing out hazards at the source: strategies for elimination
- Implementing passive and active protective mechanisms
- Effectiveness rating of risk control measures
- How to verify and validate risk controls post-implementation
- Linking risk controls to design outputs and specifications
- Using engineering prototypes to test risk control efficacy
- When to involve manufacturing in risk control execution
- Software-based risk controls: monitoring, alarms, locks
- Labelling, IFU, and training as the last line of defence
- Justifying reliance on information for safety
- Addressing residual risk due to control limitations
- Ensuring risk control integration across hardware, software, and packaging
- Verification testing specifically for risk control validation
- Failure of risk controls: what happens when protections fail
Module 6: Risk Evaluation After Risk Control - Performing residual risk assessment for each hazard-scenario pair
- Re-evaluating risk using the same criteria as initial estimation
- Determining if residual risk is acceptable for patient and user
- Justifying acceptance of residual risk with clinical benefit analysis
- Required documentation: residual risk analysis and review records
- When to require additional risk controls despite initial acceptance
- Managing risks with high severity even at low probability
- Role of clinical experts in reviewing residual risk determinations
- Auditors’ expectations when reviewing residual risk files
- Presenting residual risk conclusions to notified bodies
- Updating risk evaluation as new data becomes available
- Using traceability matrices to link controls to residual evaluations
- Handling incomplete risk control implementation during development
- Creating a risk-benefit analysis for high-profile risks
- Risk evaluation integration with clinical evaluation reports
Module 7: Overall Risk Evaluation and Management Review - Conducting an overall risk evaluation for the entire device
- Aggregating residual risks into a unified safety profile
- Balancing cumulative risk across all device functions
- Producing a summary statement of safety and clinical benefit
- Aligning with EU MDR requirements for benefit-risk determination
- Management’s role in reviewing and approving overall risk decisions
- Documenting formal management review of risk outcomes
- Ensuring alignment between risk evaluation and product launch decisions
- Leveraging risk evaluation in market access and reimbursement strategies
- Preparing for regulatory scrutiny of your overall risk justification
- Using visual dashboards to communicate overall risk posture
- Managing stakeholder concerns during overall risk review
- Updating overall risk evaluation during post-market phases
- Linking overall risk conclusions to labelling and marketing claims
- Creating an executive summary for non-technical decision-makers
Module 8: Risk Management File – Structure, Content, and Audit Readiness - Essential components of a complete risk management file
- How to structure documents for regulatory inspection efficiency
- Ensuring traceability from hazard to control to residual risk
- Linking risk management file to design history file
- Versioning, indexing, and organisation best practices
- What auditors look for in a risk management file review
- Common audit findings and how to avoid them
- Preparing for unannounced audits with a living risk file
- Using cross-references to support compliance documentation
- Creating a risk management report per ISO 14971 Clause 7.4
- Integrating risk information into technical documentation
- Handling modifications to the risk management file during device lifecycle
- Best practices for electronic records and e-signatures
- Searchability, navigation, and document control in digital files
- Standardising templates across product lines
Module 9: Production and Post-Production Activities - Transferring risk management output to production environments
- Ensuring manufacturing processes don't introduce new risks
- Monitoring for non-conformities that affect risk profile
- Integrating risk management into corrective and preventive actions (CAPA)
- How post-market surveillance feeds back into risk assessment
- Using customer complaints to trigger risk reassessment
- Updating risk files based on field reports and adverse events
- Linking post-market data to periodic risk evaluation updates
- Role of risk management in field safety corrective actions (FSCA)
- Integrating risk into post-market clinical follow-up (PMCF)
- Responding to emerging risks from real-world evidence
- Updating risk-benefit analysis based on population-level data
- Reporting updated risk assessments to notified bodies when required
- Managing risk during product modifications and upgrades
- Creating a closed-loop risk management system
Module 10: Integration with Human Factors and Usability Engineering - Linking risk management to IEC 62366 usability engineering
- Using use error analysis as a hazard identification tool
- Differentiating between use errors and device malfunctions
- Designing risk controls based on user interaction findings
- Aligning user profiles with risk scenarios
- Integrating usability test results into risk estimation
- How to mitigate risks arising from poor human-device interaction
- Using formative and summative testing data for risk validation
- Addressing high-risk use scenarios identified in testing
- Documenting risk considerations in usability engineering files
- Justifying risk controls related to user training and instructions
- Aligning risk and usability timelines during development
- Reporting usability-related risks to regulatory bodies
- Handling off-label use in risk and usability assessments
- Creating seamless integration between risk and usability teams
Module 11: Software as a Medical Device and Cybersecurity Risk - Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- Conducting an overall risk evaluation for the entire device
- Aggregating residual risks into a unified safety profile
- Balancing cumulative risk across all device functions
- Producing a summary statement of safety and clinical benefit
- Aligning with EU MDR requirements for benefit-risk determination
- Management’s role in reviewing and approving overall risk decisions
- Documenting formal management review of risk outcomes
- Ensuring alignment between risk evaluation and product launch decisions
- Leveraging risk evaluation in market access and reimbursement strategies
- Preparing for regulatory scrutiny of your overall risk justification
- Using visual dashboards to communicate overall risk posture
- Managing stakeholder concerns during overall risk review
- Updating overall risk evaluation during post-market phases
- Linking overall risk conclusions to labelling and marketing claims
- Creating an executive summary for non-technical decision-makers
Module 8: Risk Management File – Structure, Content, and Audit Readiness - Essential components of a complete risk management file
- How to structure documents for regulatory inspection efficiency
- Ensuring traceability from hazard to control to residual risk
- Linking risk management file to design history file
- Versioning, indexing, and organisation best practices
- What auditors look for in a risk management file review
- Common audit findings and how to avoid them
- Preparing for unannounced audits with a living risk file
- Using cross-references to support compliance documentation
- Creating a risk management report per ISO 14971 Clause 7.4
- Integrating risk information into technical documentation
- Handling modifications to the risk management file during device lifecycle
- Best practices for electronic records and e-signatures
- Searchability, navigation, and document control in digital files
- Standardising templates across product lines
Module 9: Production and Post-Production Activities - Transferring risk management output to production environments
- Ensuring manufacturing processes don't introduce new risks
- Monitoring for non-conformities that affect risk profile
- Integrating risk management into corrective and preventive actions (CAPA)
- How post-market surveillance feeds back into risk assessment
- Using customer complaints to trigger risk reassessment
- Updating risk files based on field reports and adverse events
- Linking post-market data to periodic risk evaluation updates
- Role of risk management in field safety corrective actions (FSCA)
- Integrating risk into post-market clinical follow-up (PMCF)
- Responding to emerging risks from real-world evidence
- Updating risk-benefit analysis based on population-level data
- Reporting updated risk assessments to notified bodies when required
- Managing risk during product modifications and upgrades
- Creating a closed-loop risk management system
Module 10: Integration with Human Factors and Usability Engineering - Linking risk management to IEC 62366 usability engineering
- Using use error analysis as a hazard identification tool
- Differentiating between use errors and device malfunctions
- Designing risk controls based on user interaction findings
- Aligning user profiles with risk scenarios
- Integrating usability test results into risk estimation
- How to mitigate risks arising from poor human-device interaction
- Using formative and summative testing data for risk validation
- Addressing high-risk use scenarios identified in testing
- Documenting risk considerations in usability engineering files
- Justifying risk controls related to user training and instructions
- Aligning risk and usability timelines during development
- Reporting usability-related risks to regulatory bodies
- Handling off-label use in risk and usability assessments
- Creating seamless integration between risk and usability teams
Module 11: Software as a Medical Device and Cybersecurity Risk - Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- Transferring risk management output to production environments
- Ensuring manufacturing processes don't introduce new risks
- Monitoring for non-conformities that affect risk profile
- Integrating risk management into corrective and preventive actions (CAPA)
- How post-market surveillance feeds back into risk assessment
- Using customer complaints to trigger risk reassessment
- Updating risk files based on field reports and adverse events
- Linking post-market data to periodic risk evaluation updates
- Role of risk management in field safety corrective actions (FSCA)
- Integrating risk into post-market clinical follow-up (PMCF)
- Responding to emerging risks from real-world evidence
- Updating risk-benefit analysis based on population-level data
- Reporting updated risk assessments to notified bodies when required
- Managing risk during product modifications and upgrades
- Creating a closed-loop risk management system
Module 10: Integration with Human Factors and Usability Engineering - Linking risk management to IEC 62366 usability engineering
- Using use error analysis as a hazard identification tool
- Differentiating between use errors and device malfunctions
- Designing risk controls based on user interaction findings
- Aligning user profiles with risk scenarios
- Integrating usability test results into risk estimation
- How to mitigate risks arising from poor human-device interaction
- Using formative and summative testing data for risk validation
- Addressing high-risk use scenarios identified in testing
- Documenting risk considerations in usability engineering files
- Justifying risk controls related to user training and instructions
- Aligning risk and usability timelines during development
- Reporting usability-related risks to regulatory bodies
- Handling off-label use in risk and usability assessments
- Creating seamless integration between risk and usability teams
Module 11: Software as a Medical Device and Cybersecurity Risk - Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- Applying ISO 14971 to standalone medical software
- Risk considerations for AI/ML-based SaMD
- Identifying software-specific hazards: crashes, data corruption, logic errors
- Handling network connectivity and data integrity risks
- Integrating security risks into the risk management process
- Using ISO 27001 and NIST frameworks to inform cybersecurity risks
- Addressing remote updates and patch management risks
- Risk implications of cloud-based medical applications
- Handling software versioning and backward compatibility risks
- Determining residual risk for algorithm-driven decisions
- Validation strategies for software risk controls
- Monitoring algorithm performance post-deployment
- Using real-world data to retrain and reassess software risk
- Complying with FDA and EU MDR expectations for SaMD risk
- Creating dynamic risk files that evolve with software iterations
Module 12: Implementation – From Theory to Practice - Applying ISO 14971 to a real Class II device project
- Step-by-step creation of a risk management plan
- Conducting hazard identification for a hypothetical infusion pump
- Estimating risk for occlusion detection failure
- Applying risk controls: hardware, alarm, labelling
- Verifying alarm response during testing
- Performing residual risk assessment after controls
- Documenting decision rationale in a traceable format
- Updating risk file based on Design Verification results
- Preparing risk management report for regulatory submission
- Conducting a mock audit of your risk file
- Responding to auditor questions with confidence
- Presenting risk outcomes to internal stakeholders
- Using lessons learned to refine your company’s risk process
- Creating a master risk template for reuse across products
Module 13: Certification and Professional Development - Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971
- Overview of The Art of Service Certificate of Completion
- How certification enhances your credibility with regulators and employers
- Adding verified achievements to your LinkedIn profile
- Using certification in job applications and performance reviews
- Preparing for advanced certifications in regulatory affairs
- Continuing professional development in risk management
- Joining a global community of certified risk management professionals
- Leveraging your new skills to lead compliance projects
- Developing a personal roadmap for ongoing mastery
- Accessing post-course resources and updates
- Receiving guidance on career advancement opportunities
- Using practical experience from the course in real assignments
- Building a portfolio of risk documentation examples
- Promoting your certification within your organisation
- Establishing yourself as the go-to expert on ISO 14971