Mastering ISO 14971 Risk Management for Medical Devices
You’re not just managing risk. You’re safeguarding lives, regulatory clearance, and your company’s future. Every unchecked hazard, every misapplied clause in ISO 14971, could become a compliance failure, a product recall, or worse. The pressure is real, and the margin for error is zero. You’ve read the standard. You’ve sat through audits. But turning ISO 14971 from a compliance obligation into a strategic advantage? That’s where most teams stall. They rely on outdated templates, incomplete interpretations, and guesswork that erodes confidence - yours and your stakeholders’. Mastering ISO 14971 Risk Management for Medical Devices isn’t another theoretical overview. It’s a precision-engineered roadmap that transforms uncertainty into clarity. This course delivers a fully justified, documented, and audit-ready risk management file - from concept to commercialisation - in as little as 21 days. One recent participant, a Senior Quality Engineer at a Class III device manufacturer, used this framework to streamline their risk management file across five product lines. The result? A zero-deficiency FDA audit and a 40% reduction in review cycles with their Notified Body. This is how you future-proof your career: by becoming the go-to authority on risk. By speaking the language of regulators with confidence. By delivering files so robust they accelerate, not delay, market access. Here’s how this course is structured to help you get there.Course Format & Delivery Details Designed for Global Professionals Who Demand Certainty
This is a self-paced, on-demand learning experience with immediate online access. You are not locked into schedules, time zones, or rigid deadlines. Learn when it fits, where it works, and at the pace that suits your role and responsibilities. Typical learners complete the core curriculum in 21–30 days, with many applying the first key deliverables - such as a compliant risk management plan or updated hazard analysis - within the first week. The faster you implement, the faster you see results. Lifetime Access, Zero Obsolescence
You receive lifetime access to the full course materials. This includes all future updates at no additional cost. As ISO 14971 guidance evolves, new regulatory expectations emerge, and best practices shift, your access updates automatically. You’ll never need to repurchase or relearn. The course is fully mobile-friendly, with 24/7 global access. Whether you're reviewing risk control measures from a clinic, preparing for an audit on a flight, or updating a file from home, your materials are always available, always secure. Expert Support Built In
You are not alone. Enrolled learners receive direct instructor support through structured guidance channels. Submit your questions, real-world scenarios, or draft documentation for feedback to align with ISO 14971 requirements and auditor expectations. This is not a forum or a chatbot. You interact with seasoned ISO 14971 practitioners who have led risk management for Class IIb and III devices across EU MDR, FDA 21 CFR Part 820, and Health Canada submissions. Certificate of Completion: Your Career Credential
Upon successful completion, you receive a Certificate of Completion issued by The Art of Service. This credential is recognised globally by regulatory professionals, quality managers, and compliance teams. It validates your mastery of ISO 14971 and demonstrates your commitment to uncompromising patient safety and regulatory rigour. No Hidden Fees. No Surprises.
The pricing structure is straightforward, ethical, and transparent. What you see is what you pay - one inclusive fee with no hidden charges, auto-renewals, or upsells. No subscription traps. Just full access, forever. We accept all major payment methods, including Visa, Mastercard, and PayPal. Payments are securely processed with bank-level encryption. Zero-Risk Enrollment: Satisfied or Refunded
We guarantee your satisfaction. If you complete the first two modules and find the course does not meet your expectations, return it within 30 days for a full refund. No forms. No hassle. No questions asked. After enrollment, you will receive a confirmation email. Your access credentials and course entry details will be delivered separately once your learner profile is fully configured - ensuring seamless, secure setup. This Works Even If…
- You’ve never led a full ISO 14971 file before
- You’re transitioning from another industry or regulatory framework
- Your team uses outdated risk management templates
- You’re preparing for an upcoming audit or Notified Body review
- English isn’t your first language
This course works because it’s not about memorisation. It’s about application. Built on real regulatory submissions, it gives you the exact structures, language, and logic that auditors expect. One Lead RA/QA Manager in Ireland used this method to rebuild their entire risk management process after a failed MDSAP audit. Within 10 weeks, the same system passed a combined TÜV and FDA review with zero observations. Your success is not left to chance. The curriculum is designed to eliminate ambiguity, reduce rework, and build your confidence with every step. You are protected by a proven system, not promises.
Module 1: Foundations of Risk Management in Medical Devices - Understanding the purpose and scope of ISO 14971
- Defining “medical device” under ISO 14971 and regulatory harmonisation
- Linking risk management to safety, performance, and clinical evaluation
- Overview of the risk management process lifecycle
- Roles and responsibilities within a risk management team
- Integrating risk management with design and development
- Aligning with ISO 13485 and regulatory quality systems
- Key definitions: risk, hazard, hazardous situation, harm, severity, probability
- Differentiating between risk analysis, evaluation, and control
- Understanding the role of risk management in post-market surveillance
Module 2: Risk Management Plan (RMP) Development - Structure and mandatory content of a compliant RMP
- Defining the product’s intended use and indications for use
- Specifying contraindications and user profiles
- Establishing risk acceptability criteria
- Documenting risk management responsibilities and authority
- Linking RMP to design history file and project timelines
- Describing risk control options and their hierarchy
- Including risk review and re-evaluation procedures
- Integrating production and post-production information
- Updating and maintaining the RMP throughout the device lifecycle
Module 3: Hazard Identification Methodologies - Systematic brainstorming techniques for hazard identification
- Using FMEA, HAZOP, and fault tree analysis in early design stages
- Reviewing literature, standards, and competitor incidents
- Evaluating foreseeable misuse and off-label use
- Identifying hazards related to materials and biocompatibility
- Assessing software-related hazards in SaMD and embedded systems
- Considering environmental and electromagnetic interference hazards
- Analyzing user interface and human factors-related hazards
- Reviewing mechanical, electrical, and thermal hazards
- Addressing sterilisation, packaging, and shelf life hazards
Module 4: Estimating and Evaluating Risk - Selecting risk estimation methods: qualitative vs. quantitative
- Developing severity scales with clinical justification
- Establishing probability of occurrence scales with real-world data
- Constructing a risk matrix tailored to your device class
- Defining risk acceptability using ALARP and other principles
- Applying ISO/TR 24971 guidance on risk evaluation
- Documenting rationale for accepting residual risk
- Managing risks related to combination products
- Evaluating risks in multi-functional devices
- Handling emerging risks during clinical use
Module 5: Risk Control Strategies and Hierarchy - Understanding the three-part risk control hierarchy
- Designing out hazards through inherent safety by design
- Implementing protective measures in medical device design
- Developing safety-related information for users and caregivers
- Combining multiple risk controls for high-risk scenarios
- Validating effectiveness of risk controls through testing
- Linking risk controls to design inputs and verification
- Documenting rationale when risk controls cannot reduce risk
- Managing trade-offs between usability and safety
- Using standards compliance as a risk control measure
Module 6: Risk Control Verification and Validation - Planning verification activities for each risk control
- Designing test protocols that prove risk control effectiveness
- Conducting usability testing as a verification method
- Using simulation and bench testing for hazard mitigation
- Integrating software validation into risk control verification
- Validating labelling and IFU as risk control measures
- Linking verification outcomes to the risk management file
- Handling non-conformities and failed verifications
- Documenting verification results with traceability
- Ensuring repeatable and reproducible verification processes
Module 7: Residual Risk Evaluation and Acceptability - Reassessing risks after implementation of controls
- Calculating residual risk using updated probability and severity
- Determining acceptability based on defined criteria
- Documenting rationale for accepting residual risk
- Involving clinical experts in residual risk review
- Presenting residual risk to regulatory bodies and auditors
- Updating risk management files when new data emerges
- Managing residual risks in patient populations
- Linking residual risk to benefit-risk analysis
- Communicating residual risk in labelling and promotional materials
Module 8: Risk Management File (RMF) Documentation - Assembling a complete and compliant RMF
- Structure of the RMF: index, version history, and revision control
- Linking RMF to DHF, DMR, and technical documentation
- Ensuring traceability from hazards to controls to verification
- Integrating risk management into the device master record
- Maintaining confidentiality and access controls
- Using electronic document management systems
- Audit readiness: preparing RMF for inspection
- Documenting updates and changes to the RMF
- Incorporating post-market feedback into RMF updates
Module 9: Production and Post-Production Risk Monitoring - Establishing feedback loops from manufacturing
- Linking non-conformances to risk management processes
- Integrating complaint handling with risk review
- Analysing field safety corrective actions (FSCAs)
- Using post-market surveillance data for risk re-evaluation
- Updating risk assessments based on real-world use
- Incorporating PMS reports into periodic risk reviews
- Managing software updates and patches as risk events
- Conducting trend analysis of complaint data
- Reporting significant risk changes to regulatory authorities
Module 10: Periodic Risk Review and Re-Evaluation - Scheduling risk reviews based on device class and risk level
- Identifying triggers for unscheduled risk reviews
- Conducting formal risk review meetings with cross-functional teams
- Documenting outcomes and decisions from risk reviews
- Updating risk acceptability criteria over time
- Reassessing clinical benefit in light of new data
- Managing risks related to product modifications
- Reviewing legacy devices without current risk files
- Handling obsolescence and end-of-life risk management
- Linking periodic reviews to management review cycles
Module 11: Integration with Regulatory Submissions - Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Understanding the purpose and scope of ISO 14971
- Defining “medical device” under ISO 14971 and regulatory harmonisation
- Linking risk management to safety, performance, and clinical evaluation
- Overview of the risk management process lifecycle
- Roles and responsibilities within a risk management team
- Integrating risk management with design and development
- Aligning with ISO 13485 and regulatory quality systems
- Key definitions: risk, hazard, hazardous situation, harm, severity, probability
- Differentiating between risk analysis, evaluation, and control
- Understanding the role of risk management in post-market surveillance
Module 2: Risk Management Plan (RMP) Development - Structure and mandatory content of a compliant RMP
- Defining the product’s intended use and indications for use
- Specifying contraindications and user profiles
- Establishing risk acceptability criteria
- Documenting risk management responsibilities and authority
- Linking RMP to design history file and project timelines
- Describing risk control options and their hierarchy
- Including risk review and re-evaluation procedures
- Integrating production and post-production information
- Updating and maintaining the RMP throughout the device lifecycle
Module 3: Hazard Identification Methodologies - Systematic brainstorming techniques for hazard identification
- Using FMEA, HAZOP, and fault tree analysis in early design stages
- Reviewing literature, standards, and competitor incidents
- Evaluating foreseeable misuse and off-label use
- Identifying hazards related to materials and biocompatibility
- Assessing software-related hazards in SaMD and embedded systems
- Considering environmental and electromagnetic interference hazards
- Analyzing user interface and human factors-related hazards
- Reviewing mechanical, electrical, and thermal hazards
- Addressing sterilisation, packaging, and shelf life hazards
Module 4: Estimating and Evaluating Risk - Selecting risk estimation methods: qualitative vs. quantitative
- Developing severity scales with clinical justification
- Establishing probability of occurrence scales with real-world data
- Constructing a risk matrix tailored to your device class
- Defining risk acceptability using ALARP and other principles
- Applying ISO/TR 24971 guidance on risk evaluation
- Documenting rationale for accepting residual risk
- Managing risks related to combination products
- Evaluating risks in multi-functional devices
- Handling emerging risks during clinical use
Module 5: Risk Control Strategies and Hierarchy - Understanding the three-part risk control hierarchy
- Designing out hazards through inherent safety by design
- Implementing protective measures in medical device design
- Developing safety-related information for users and caregivers
- Combining multiple risk controls for high-risk scenarios
- Validating effectiveness of risk controls through testing
- Linking risk controls to design inputs and verification
- Documenting rationale when risk controls cannot reduce risk
- Managing trade-offs between usability and safety
- Using standards compliance as a risk control measure
Module 6: Risk Control Verification and Validation - Planning verification activities for each risk control
- Designing test protocols that prove risk control effectiveness
- Conducting usability testing as a verification method
- Using simulation and bench testing for hazard mitigation
- Integrating software validation into risk control verification
- Validating labelling and IFU as risk control measures
- Linking verification outcomes to the risk management file
- Handling non-conformities and failed verifications
- Documenting verification results with traceability
- Ensuring repeatable and reproducible verification processes
Module 7: Residual Risk Evaluation and Acceptability - Reassessing risks after implementation of controls
- Calculating residual risk using updated probability and severity
- Determining acceptability based on defined criteria
- Documenting rationale for accepting residual risk
- Involving clinical experts in residual risk review
- Presenting residual risk to regulatory bodies and auditors
- Updating risk management files when new data emerges
- Managing residual risks in patient populations
- Linking residual risk to benefit-risk analysis
- Communicating residual risk in labelling and promotional materials
Module 8: Risk Management File (RMF) Documentation - Assembling a complete and compliant RMF
- Structure of the RMF: index, version history, and revision control
- Linking RMF to DHF, DMR, and technical documentation
- Ensuring traceability from hazards to controls to verification
- Integrating risk management into the device master record
- Maintaining confidentiality and access controls
- Using electronic document management systems
- Audit readiness: preparing RMF for inspection
- Documenting updates and changes to the RMF
- Incorporating post-market feedback into RMF updates
Module 9: Production and Post-Production Risk Monitoring - Establishing feedback loops from manufacturing
- Linking non-conformances to risk management processes
- Integrating complaint handling with risk review
- Analysing field safety corrective actions (FSCAs)
- Using post-market surveillance data for risk re-evaluation
- Updating risk assessments based on real-world use
- Incorporating PMS reports into periodic risk reviews
- Managing software updates and patches as risk events
- Conducting trend analysis of complaint data
- Reporting significant risk changes to regulatory authorities
Module 10: Periodic Risk Review and Re-Evaluation - Scheduling risk reviews based on device class and risk level
- Identifying triggers for unscheduled risk reviews
- Conducting formal risk review meetings with cross-functional teams
- Documenting outcomes and decisions from risk reviews
- Updating risk acceptability criteria over time
- Reassessing clinical benefit in light of new data
- Managing risks related to product modifications
- Reviewing legacy devices without current risk files
- Handling obsolescence and end-of-life risk management
- Linking periodic reviews to management review cycles
Module 11: Integration with Regulatory Submissions - Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Systematic brainstorming techniques for hazard identification
- Using FMEA, HAZOP, and fault tree analysis in early design stages
- Reviewing literature, standards, and competitor incidents
- Evaluating foreseeable misuse and off-label use
- Identifying hazards related to materials and biocompatibility
- Assessing software-related hazards in SaMD and embedded systems
- Considering environmental and electromagnetic interference hazards
- Analyzing user interface and human factors-related hazards
- Reviewing mechanical, electrical, and thermal hazards
- Addressing sterilisation, packaging, and shelf life hazards
Module 4: Estimating and Evaluating Risk - Selecting risk estimation methods: qualitative vs. quantitative
- Developing severity scales with clinical justification
- Establishing probability of occurrence scales with real-world data
- Constructing a risk matrix tailored to your device class
- Defining risk acceptability using ALARP and other principles
- Applying ISO/TR 24971 guidance on risk evaluation
- Documenting rationale for accepting residual risk
- Managing risks related to combination products
- Evaluating risks in multi-functional devices
- Handling emerging risks during clinical use
Module 5: Risk Control Strategies and Hierarchy - Understanding the three-part risk control hierarchy
- Designing out hazards through inherent safety by design
- Implementing protective measures in medical device design
- Developing safety-related information for users and caregivers
- Combining multiple risk controls for high-risk scenarios
- Validating effectiveness of risk controls through testing
- Linking risk controls to design inputs and verification
- Documenting rationale when risk controls cannot reduce risk
- Managing trade-offs between usability and safety
- Using standards compliance as a risk control measure
Module 6: Risk Control Verification and Validation - Planning verification activities for each risk control
- Designing test protocols that prove risk control effectiveness
- Conducting usability testing as a verification method
- Using simulation and bench testing for hazard mitigation
- Integrating software validation into risk control verification
- Validating labelling and IFU as risk control measures
- Linking verification outcomes to the risk management file
- Handling non-conformities and failed verifications
- Documenting verification results with traceability
- Ensuring repeatable and reproducible verification processes
Module 7: Residual Risk Evaluation and Acceptability - Reassessing risks after implementation of controls
- Calculating residual risk using updated probability and severity
- Determining acceptability based on defined criteria
- Documenting rationale for accepting residual risk
- Involving clinical experts in residual risk review
- Presenting residual risk to regulatory bodies and auditors
- Updating risk management files when new data emerges
- Managing residual risks in patient populations
- Linking residual risk to benefit-risk analysis
- Communicating residual risk in labelling and promotional materials
Module 8: Risk Management File (RMF) Documentation - Assembling a complete and compliant RMF
- Structure of the RMF: index, version history, and revision control
- Linking RMF to DHF, DMR, and technical documentation
- Ensuring traceability from hazards to controls to verification
- Integrating risk management into the device master record
- Maintaining confidentiality and access controls
- Using electronic document management systems
- Audit readiness: preparing RMF for inspection
- Documenting updates and changes to the RMF
- Incorporating post-market feedback into RMF updates
Module 9: Production and Post-Production Risk Monitoring - Establishing feedback loops from manufacturing
- Linking non-conformances to risk management processes
- Integrating complaint handling with risk review
- Analysing field safety corrective actions (FSCAs)
- Using post-market surveillance data for risk re-evaluation
- Updating risk assessments based on real-world use
- Incorporating PMS reports into periodic risk reviews
- Managing software updates and patches as risk events
- Conducting trend analysis of complaint data
- Reporting significant risk changes to regulatory authorities
Module 10: Periodic Risk Review and Re-Evaluation - Scheduling risk reviews based on device class and risk level
- Identifying triggers for unscheduled risk reviews
- Conducting formal risk review meetings with cross-functional teams
- Documenting outcomes and decisions from risk reviews
- Updating risk acceptability criteria over time
- Reassessing clinical benefit in light of new data
- Managing risks related to product modifications
- Reviewing legacy devices without current risk files
- Handling obsolescence and end-of-life risk management
- Linking periodic reviews to management review cycles
Module 11: Integration with Regulatory Submissions - Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Understanding the three-part risk control hierarchy
- Designing out hazards through inherent safety by design
- Implementing protective measures in medical device design
- Developing safety-related information for users and caregivers
- Combining multiple risk controls for high-risk scenarios
- Validating effectiveness of risk controls through testing
- Linking risk controls to design inputs and verification
- Documenting rationale when risk controls cannot reduce risk
- Managing trade-offs between usability and safety
- Using standards compliance as a risk control measure
Module 6: Risk Control Verification and Validation - Planning verification activities for each risk control
- Designing test protocols that prove risk control effectiveness
- Conducting usability testing as a verification method
- Using simulation and bench testing for hazard mitigation
- Integrating software validation into risk control verification
- Validating labelling and IFU as risk control measures
- Linking verification outcomes to the risk management file
- Handling non-conformities and failed verifications
- Documenting verification results with traceability
- Ensuring repeatable and reproducible verification processes
Module 7: Residual Risk Evaluation and Acceptability - Reassessing risks after implementation of controls
- Calculating residual risk using updated probability and severity
- Determining acceptability based on defined criteria
- Documenting rationale for accepting residual risk
- Involving clinical experts in residual risk review
- Presenting residual risk to regulatory bodies and auditors
- Updating risk management files when new data emerges
- Managing residual risks in patient populations
- Linking residual risk to benefit-risk analysis
- Communicating residual risk in labelling and promotional materials
Module 8: Risk Management File (RMF) Documentation - Assembling a complete and compliant RMF
- Structure of the RMF: index, version history, and revision control
- Linking RMF to DHF, DMR, and technical documentation
- Ensuring traceability from hazards to controls to verification
- Integrating risk management into the device master record
- Maintaining confidentiality and access controls
- Using electronic document management systems
- Audit readiness: preparing RMF for inspection
- Documenting updates and changes to the RMF
- Incorporating post-market feedback into RMF updates
Module 9: Production and Post-Production Risk Monitoring - Establishing feedback loops from manufacturing
- Linking non-conformances to risk management processes
- Integrating complaint handling with risk review
- Analysing field safety corrective actions (FSCAs)
- Using post-market surveillance data for risk re-evaluation
- Updating risk assessments based on real-world use
- Incorporating PMS reports into periodic risk reviews
- Managing software updates and patches as risk events
- Conducting trend analysis of complaint data
- Reporting significant risk changes to regulatory authorities
Module 10: Periodic Risk Review and Re-Evaluation - Scheduling risk reviews based on device class and risk level
- Identifying triggers for unscheduled risk reviews
- Conducting formal risk review meetings with cross-functional teams
- Documenting outcomes and decisions from risk reviews
- Updating risk acceptability criteria over time
- Reassessing clinical benefit in light of new data
- Managing risks related to product modifications
- Reviewing legacy devices without current risk files
- Handling obsolescence and end-of-life risk management
- Linking periodic reviews to management review cycles
Module 11: Integration with Regulatory Submissions - Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Reassessing risks after implementation of controls
- Calculating residual risk using updated probability and severity
- Determining acceptability based on defined criteria
- Documenting rationale for accepting residual risk
- Involving clinical experts in residual risk review
- Presenting residual risk to regulatory bodies and auditors
- Updating risk management files when new data emerges
- Managing residual risks in patient populations
- Linking residual risk to benefit-risk analysis
- Communicating residual risk in labelling and promotional materials
Module 8: Risk Management File (RMF) Documentation - Assembling a complete and compliant RMF
- Structure of the RMF: index, version history, and revision control
- Linking RMF to DHF, DMR, and technical documentation
- Ensuring traceability from hazards to controls to verification
- Integrating risk management into the device master record
- Maintaining confidentiality and access controls
- Using electronic document management systems
- Audit readiness: preparing RMF for inspection
- Documenting updates and changes to the RMF
- Incorporating post-market feedback into RMF updates
Module 9: Production and Post-Production Risk Monitoring - Establishing feedback loops from manufacturing
- Linking non-conformances to risk management processes
- Integrating complaint handling with risk review
- Analysing field safety corrective actions (FSCAs)
- Using post-market surveillance data for risk re-evaluation
- Updating risk assessments based on real-world use
- Incorporating PMS reports into periodic risk reviews
- Managing software updates and patches as risk events
- Conducting trend analysis of complaint data
- Reporting significant risk changes to regulatory authorities
Module 10: Periodic Risk Review and Re-Evaluation - Scheduling risk reviews based on device class and risk level
- Identifying triggers for unscheduled risk reviews
- Conducting formal risk review meetings with cross-functional teams
- Documenting outcomes and decisions from risk reviews
- Updating risk acceptability criteria over time
- Reassessing clinical benefit in light of new data
- Managing risks related to product modifications
- Reviewing legacy devices without current risk files
- Handling obsolescence and end-of-life risk management
- Linking periodic reviews to management review cycles
Module 11: Integration with Regulatory Submissions - Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Establishing feedback loops from manufacturing
- Linking non-conformances to risk management processes
- Integrating complaint handling with risk review
- Analysing field safety corrective actions (FSCAs)
- Using post-market surveillance data for risk re-evaluation
- Updating risk assessments based on real-world use
- Incorporating PMS reports into periodic risk reviews
- Managing software updates and patches as risk events
- Conducting trend analysis of complaint data
- Reporting significant risk changes to regulatory authorities
Module 10: Periodic Risk Review and Re-Evaluation - Scheduling risk reviews based on device class and risk level
- Identifying triggers for unscheduled risk reviews
- Conducting formal risk review meetings with cross-functional teams
- Documenting outcomes and decisions from risk reviews
- Updating risk acceptability criteria over time
- Reassessing clinical benefit in light of new data
- Managing risks related to product modifications
- Reviewing legacy devices without current risk files
- Handling obsolescence and end-of-life risk management
- Linking periodic reviews to management review cycles
Module 11: Integration with Regulatory Submissions - Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Extracting key risk documentation for 510(k) submissions
- Preparing risk summaries for PMA applications
- Meeting EU MDR Annex I and Annex II requirements
- Aligning risk management with technical documentation structure
- Using RMF as evidence of conformity for CE marking
- Supporting Health Canada and TGA submissions
- Responding to audit findings related to risk management
- Preparing defence dossiers for regulatory inquiries
- Linking risk to clinical evaluation reports (CERs)
- Providing risk justification in pre-submission meetings
Module 12: Risk Management for Software as a Medical Device (SaMD) - Applying ISO 14971 to AI and machine learning algorithms
- Identifying hazards in cloud-based diagnostics
- Managing data privacy and cybersecurity risks
- Risk classification of software functions
- Validating risk controls in agile development
- Handling software updates and version drift
- Using simulated clinical environments for validation
- Documenting algorithmic bias as a risk factor
- Integrating software failure modes into FMEA
- Ensuring traceability from code changes to risk documentation
Module 13: Risk in Combination Products and IVDs - Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Adapting ISO 14971 for drug-device combinations
- Managing risks at the interface of drug and device
- Assessing risks in delivery systems (e.g. auto-injectors)
- Applying risk principles to in vitro diagnostic devices
- Linking analytical and clinical performance to risk
- Risk considerations for near-patient testing
- Handling contamination, carryover, and sample mix-up risks
- Validating user training as a risk control for IVDs
- Managing risks in LDTs and lab-developed tests
- Addressing software risks in IVD data interpretation
Module 14: Human Factors and Usability Engineering Integration - Linking usability studies to hazard identification
- Using formative evaluations to uncover use errors
- Documenting user profiles and use environments
- Analysing task-based risks in home care settings
- Mapping use scenarios to risk control measures
- Validating labels, symbols, and IFUs as risk controls
- Integrating summative testing results into risk files
- Managing risks for elderly, paediatric, or impaired users
- Handling emergency vs. routine use scenarios
- Aligning with IEC 62366-1 requirements
Module 15: Risk Management for Legacy Devices - Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Conducting post-rationalisation for older devices
- Reconstructing risk files without original design data
- Using field performance data to justify current risk levels
- Updating risk files under new regulatory regimes
- Managing risk documentation during mergers and acquisitions
- Addressing obsolescence of components and materials
- Re-evaluating risk after manufacturing site transfers
- Handling risk for discontinued but still in-use devices
- Obtaining clinical expert opinions for legacy risk acceptance
- Justifying continued marketing based on risk-benefit
Module 16: Risk in Clinical Investigations and Feasibility Studies - Developing risk management plans for first-in-human trials
- Identifying device-related risks in clinical protocols
- Linking adverse event reporting to risk evaluation
- Managing risks in adaptive trial designs
- Conducting risk-benefit analysis for trial continuation
- Involving IRBs and ethics committees in risk discussions
- Updating risk assessments during trial pauses or halts
- Documenting informed consent in relation to known risks
- Managing risks in multi-centre and global trials
- Using preliminary clinical data to refine controls
Module 17: Advanced Risk Analysis Tools and Techniques - Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Conducting Failure Mode and Effects Analysis (FMEA)
- Applying Fault Tree Analysis (FTA) for complex systems
- Using bow-tie analysis for high-consequence risks
- Implementing hazard operability studies (HAZOP)
- Integrating reliability block diagrams (RBD)
- Calculating single-fault condition tolerance
- Modelling cascading failure scenarios
- Using Bayesian networks for probabilistic risk assessment
- Estimating fatigue and wear-related failure risks
- Applying Monte Carlo simulations for uncertainty analysis
Module 18: Risk Communication and Stakeholder Engagement - Writing clear risk summaries for non-expert audiences
- Presenting risk information to senior management
- Communicating residual risk to clinical teams
- Developing risk disclosure statements for patients
- Training sales and marketing teams on risk messaging
- Handling media inquiries related to device risk
- Using dashboards to visualise risk data
- Reporting critical risks to boards and investors
- Establishing escalation paths for urgent risks
- Managing external consultants in risk projects
Module 19: Risk Management Audits and Inspections - Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems
Module 20: Certification, Career Advancement & Next Steps - Submitting your Certificate of Completion to HR and supervisors
- Adding your credential to LinkedIn and professional profiles
- Leveraging certification in job interviews and promotions
- Using the course project as a portfolio piece
- Accessing alumni resources and expert networks
- Joining advanced training pathways in regulatory affairs
- Expanding into related standards: IEC 60601, ISO 15223
- Preparing for RAC, CQA, or other regulatory certifications
- Mentoring others in risk management best practices
- Becoming the recognised risk authority in your organisation
- Preparing for FDA, TÜV, BSI, and other audits
- Organising RMF for easy auditor navigation
- Anticipating common audit findings and objections
- Using checklists to self-audit your risk file
- Demonstrating traceability from hazard to control
- Responding to deficiency letters and questions
- Conducting internal audits of risk processes
- Training teams on audit response protocols
- Documenting corrective actions from audit findings
- Using audit outcomes to improve risk systems