ISO 14971 Risk Management for Medical Devices A Complete Guide
You’re responsible for ensuring medical devices are safe. Lives depend on it. Regulatory auditors are watching. Your team expects clarity. Yet right now, ISO 14971 might feel like a maze of ambiguous clauses, disconnected templates, and reactive firefighting. You’re not just under pressure to comply-you’re expected to lead with confidence, anticipate risk, and deliver documentation that holds up under scrutiny. What if you could transform that uncertainty into mastery? What if you had a complete, step-by-step system to interpret ISO 14971 with precision, integrate risk management into every phase of your development lifecycle, and build airtight files that regulators trust? Not hypotheticals-practical, enforceable processes used by top-tier medical device companies. The ISO 14971 Risk Management for Medical Devices A Complete Guide is not another theory dump. It’s your engineered path from fragmented compliance to structured excellence. In as little as 14 days, you’ll go from struggling with risk files to producing comprehensive, audit-ready documentation with consistent traceability from hazard to control to verification. Take Mark T., a Principal Quality Engineer at a Class II device manufacturer in Germany. Before this course, his team spent over 30 hours a week chasing documentation gaps. After completing the program, he restructured their entire risk management file using the course’s workflow templates. The result? A clean ISO 13485 audit with zero major nonconformities-and recognition from senior leadership as the go-to risk authority. This isn’t about checking a box. It’s about becoming the indispensable expert your organisation relies on when device safety is on the line. It’s about turning risk management from a compliance burden into a competitive advantage. Here’s how this course is structured to help you get there.Course Format & Delivery Details Learn on Your Terms – No Deadlines, No Pressure
This course is fully self-paced with immediate online access upon enrollment. There are no fixed start dates, live sessions, or time commitments. You decide when and where you study. Whether you have 20 minutes between meetings or a clear morning to dive deep, the structure adapts to your schedule. Most learners complete the core curriculum in 12 to 18 hours, with many reporting first actionable results-like completing a risk management plan or revising a hazard analysis-in under 72 hours of starting. Lifetime Access, Infinite Updates
Once enrolled, you receive lifetime access to all course materials. This includes every update, revision, and enhancement made in response to changes in ISO 14971, regulatory expectations, or industry best practices-free of charge. Medical device standards evolve. Your knowledge stays ahead. Your access is secure, mobile-friendly, and available 24/7 from any device, anywhere in the world. Study during international travel, offline on a tablet, or from your workstation-your progress is always synced and accessible. Expert-Led Support with Real Accountability
You’re not learning in isolation. Throughout the course, you have direct access to instructor support for clarifications, practical guidance, and implementation feedback. This isn’t automated chat or FAQ redirects-it’s real human insight from seasoned medical device compliance professionals who’ve led risk programs for Class III devices and global submissions. Ask specific questions about your device type, regulatory pathway, or unique risk scenario. Receive actionable responses that help you apply concepts to your real-world work. Certificate of Completion – Globally Recognised
Upon finishing the course, you’ll earn a formal Certificate of Completion issued by The Art of Service. This credential is trusted by employers across 86 countries. It verifies your mastery of ISO 14971 in practice-not just theory-and enhances your professional credibility with regulators, auditors, and hiring managers alike. Many learners report using the certificate to justify promotions, salary increases, or successful job transitions into Regulatory Affairs, Quality Assurance, and Safety Engineering roles. Transparent Pricing, Zero Hidden Fees
The price you see is the price you pay. There are no recurring charges, upsells, or surprise fees. The course is a one-time investment with lifetime value. We accept all major payment methods including Visa, Mastercard, and PayPal. 100% Satisfaction Guaranteed – Learn with Zero Risk
We offer a full money-back guarantee. If the course doesn’t meet your expectations, you can request a refund at any time-no questions asked. This eliminates all financial risk and puts trust squarely on your side. Instant Confirmation – Seamless Onboarding
After enrollment, you’ll receive a confirmation email. Once the course materials are ready, your access details will be sent separately. This ensures every resource is fully prepared and optimised for your learning experience. This Works for You - Even If…
You’ve tried other risk management training and found it too academic. Even if your device is high-risk, novel, or falls into an emerging technology category. Even if you’re new to medical devices or transitioning from another industry. Even if your company lacks a formal risk culture. Our structured methodology works because it’s based on real-world templates, regulatory precedents, and documented success patterns-not ideals. Over 4,200 professionals-from Biomedical Engineers in Brazil to Regulatory Managers in Singapore-have used this system to master ISO 14971 under real deadlines, real audits, and real patient safety pressures. You don’t need prior expertise in risk management. You just need the willingness to follow a proven framework. Every tool, every form, every workflow is designed for immediate use in your job. This is your risk-free opportunity to gain clarity, credibility, and career leverage in one of the most critical domains of medical device development.
Module 1: Foundations of Medical Device Risk Management - Understanding the purpose and scope of ISO 14971
- Key definitions: risk, harm, hazard, hazardous situation, and severity
- Differentiating between risk management and quality management
- The role of risk in the medical device lifecycle
- Regulatory context: how ISO 14971 aligns with FDA, MHRA, TGA, and EU MDR
- Linking risk management to product safety and clinical evaluation
- The evolution of ISO 14971: from 2007 to current edition
- Core principles of proactive versus reactive risk strategies
- Introduction to risk acceptability and the ALARP principle
- Understanding residual risk and its documentation requirements
- Role of top management in risk oversight
- Setting risk policy and risk acceptance criteria at the organisational level
- Practical example: risk framework for a Class II infusion pump
- Common misconceptions about risk management compliance
- How risk management prevents recalls and field safety notices
Module 2: Establishing a Risk Management Framework - Creating a risk management plan: structure and mandatory content
- Defining roles and responsibilities within the risk team
- Integrating risk management into your QMS
- Developing organisational risk philosophy and policy
- Setting risk acceptability criteria: qualitative vs quantitative methods
- Mapping risk activities to design and development stages
- Document control and versioning for risk files
- Traceability between risk management and other quality processes
- Using flowcharts to visualise the risk management process
- Establishing interfaces with design history file (DHF) and technical documentation
- Managing subcontractors and their role in risk activities
- Defining the risk management file structure
- Overview of risk management file audit readiness
- How to maintain living documents in dynamic development environments
- Allocating resources and time for risk activities
Module 3: Identifying Hazards and Hazardous Situations - Systematic approach to hazard identification
- Functional and physical analysis of medical devices
- Using use case analysis to uncover user-related hazards
- FMEA basics applied to medical device risk
- Leveraging clinical data and literature to anticipate hazards
- Input from usability engineering and human factors
- Identifying hazards related to software and AI functionality
- Hazards from accessories, consumables, and ancillary equipment
- Environmental and site-of-use factors (home vs hospital)
- Considering foreseeable misuse and off-label use
- Failure mode analysis: hardware, software, mechanical, electrical
- Chemical and biological hazards from materials
- Service and maintenance-induced hazards
- Labeling and instructions for use as a source of hazard
- Post-market data integration into hazard identification
Module 4: Risk Analysis – Estimating and Evaluating Risk - Determining the probability of occurrence of harm
- Assessing severity of harm: minor, serious, critical, fatal
- Building a risk estimation matrix with consistent scoring
- Quantitative vs qualitative risk estimation approaches
- Incorporating engineering judgment with documented rationale
- Using historical failure data to inform probability estimates
- Factoring in user population vulnerability
- Evaluating risk for combination products and connected devices
- Considering rare but high-severity events
- Documentation of risk estimation rationale for auditors
- Distinguishing between exposure and harm probability
- Estimating risk for software-driven decisions
- Risk evaluation against predefined acceptability criteria
- Handling borderline and subjective risk assessments
- Peer review processes for risk evaluation rigor
Module 5: Risk Control Measures and Implementation - Applying the risk control hierarchy: inherent safety, protective measures, information
- Designing out hazards through engineering controls
- Implementing alarms, interlocks, and safeguards
- Failure detection and system diagnostics as risk controls
- Software reliability and redundancy strategies
- Labelling and IFU as a last line of defense
- Determining when risk controls are sufficient
- Linking controls to specific hazards and hazardous situations
- Verification of implemented risk controls
- Documenting rationale for selected control options
- Managing trade-offs between usability and safety
- Design validation of risk controls under real-use conditions
- Integration with design inputs and verification protocols
- Ensuring controls do not introduce new hazards
- Use of safety architectures and fault-tolerant design
Module 6: Risk Management File Structure and Documentation - Complete structure of a risk management file
- ISO 14971 Annex Z compliance checklist
- Creating a risk analysis report with full traceability
- Linking hazards to risk controls in a traceability matrix
- Documenting residual risk and evaluation for acceptability
- Writing comprehensive risk management reports
- Ensuring clarity and consistency across risk documents
- Version control and change management in risk files
- Archiving and retention requirements
- Risk file review and approval processes
- Audit-ready formatting and indexing strategies
- Using tables, diagrams, and annotations effectively
- Summary of benefits versus residual risk
- Handling multiple variants and product families
- Role of risk files in technical documentation for EU MDR
Module 7: Evaluation of Overall Residual Risk - Definition and regulatory expectations for overall residual risk
- Methods for aggregating residual risks across the device
- Role of top management in approving overall residual risk
- Documenting decision rationale with supporting evidence
- Using benefit-risk analysis to justify residual risk
- Incorporating clinical data and risk-benefit evaluation
- Tools for visualising overall residual risk (heat maps, dashboards)
- Presentation formats for management review
- Handling situations where residual risk is not clearly acceptable
- Engaging clinical experts in risk-benefit assessment
- Linking to post-market surveillance planning
- Handling life-sustaining or life-supporting devices
- External review and advisory board involvement
- Documentation required for notified body submissions
- Updating overall residual risk after design changes
Module 8: Risk Management in Design and Development - Integrating risk activities into stage-gate processes
- Risk input into design inputs and specifications
- Using risk to drive design verification and validation
- Risk assessment during prototyping and early testing
- Hazard analysis during design transfer
- Impact of design changes on risk management file
- Change control integration with risk evaluation
- Risk documentation for design history file (DHF)
- Ensuring risk traceability from concept to production
- Use of design reviews for risk validation
- Role of risk in usability testing and formative studies
- Risk assessment of material and supplier changes
- FMEA update during design iterations
- Linking risk to risk-based testing strategies
- Documentation requirements for design freeze and final release
Module 9: Production and Post-Production Risk Activities - Continuity of risk management after design transfer
- Handling nonconformances and CAPA from a risk perspective
- Use of production data to inform risk analysis
- Incorporating supplier nonconformances into risk files
- Risk-based internal audit planning
- Monitoring process deviations for risk impact
- Using field failure data to reassess risk
- Feedback loop from post-market surveillance
- Handling complaints and adverse events as risk inputs
- Software updates and patch management risks
- Service and repair process risk considerations
- Labeling changes and their impact on risk
- Outsourced manufacturing and sterilisation risks
- Managing risk during scale-up and ramp-up phases
- Periodic review of risk management file
Module 10: Risk Management for Software and Connected Devices - Unique hazards in software-based medical devices
- IEC 62304 alignment with ISO 14971
- Risk analysis for software failure modes
- Data integrity, corruption, and transmission risks
- AI and machine learning decision-making risks
- Network and cybersecurity hazards
- Remote monitoring and telehealth risks
- Over-the-air (OTA) update risks
- User authentication and access control failures
- Cloud-based processing and data storage risks
- Latency and connectivity loss scenarios
- Interoperability risks with other systems
- Algorithm drift and performance degradation
- Ensuring software risk controls are validated
- Documentation strategies for software risk files
Module 11: Risk Management for Combination Products and Novel Technologies - Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Understanding the purpose and scope of ISO 14971
- Key definitions: risk, harm, hazard, hazardous situation, and severity
- Differentiating between risk management and quality management
- The role of risk in the medical device lifecycle
- Regulatory context: how ISO 14971 aligns with FDA, MHRA, TGA, and EU MDR
- Linking risk management to product safety and clinical evaluation
- The evolution of ISO 14971: from 2007 to current edition
- Core principles of proactive versus reactive risk strategies
- Introduction to risk acceptability and the ALARP principle
- Understanding residual risk and its documentation requirements
- Role of top management in risk oversight
- Setting risk policy and risk acceptance criteria at the organisational level
- Practical example: risk framework for a Class II infusion pump
- Common misconceptions about risk management compliance
- How risk management prevents recalls and field safety notices
Module 2: Establishing a Risk Management Framework - Creating a risk management plan: structure and mandatory content
- Defining roles and responsibilities within the risk team
- Integrating risk management into your QMS
- Developing organisational risk philosophy and policy
- Setting risk acceptability criteria: qualitative vs quantitative methods
- Mapping risk activities to design and development stages
- Document control and versioning for risk files
- Traceability between risk management and other quality processes
- Using flowcharts to visualise the risk management process
- Establishing interfaces with design history file (DHF) and technical documentation
- Managing subcontractors and their role in risk activities
- Defining the risk management file structure
- Overview of risk management file audit readiness
- How to maintain living documents in dynamic development environments
- Allocating resources and time for risk activities
Module 3: Identifying Hazards and Hazardous Situations - Systematic approach to hazard identification
- Functional and physical analysis of medical devices
- Using use case analysis to uncover user-related hazards
- FMEA basics applied to medical device risk
- Leveraging clinical data and literature to anticipate hazards
- Input from usability engineering and human factors
- Identifying hazards related to software and AI functionality
- Hazards from accessories, consumables, and ancillary equipment
- Environmental and site-of-use factors (home vs hospital)
- Considering foreseeable misuse and off-label use
- Failure mode analysis: hardware, software, mechanical, electrical
- Chemical and biological hazards from materials
- Service and maintenance-induced hazards
- Labeling and instructions for use as a source of hazard
- Post-market data integration into hazard identification
Module 4: Risk Analysis – Estimating and Evaluating Risk - Determining the probability of occurrence of harm
- Assessing severity of harm: minor, serious, critical, fatal
- Building a risk estimation matrix with consistent scoring
- Quantitative vs qualitative risk estimation approaches
- Incorporating engineering judgment with documented rationale
- Using historical failure data to inform probability estimates
- Factoring in user population vulnerability
- Evaluating risk for combination products and connected devices
- Considering rare but high-severity events
- Documentation of risk estimation rationale for auditors
- Distinguishing between exposure and harm probability
- Estimating risk for software-driven decisions
- Risk evaluation against predefined acceptability criteria
- Handling borderline and subjective risk assessments
- Peer review processes for risk evaluation rigor
Module 5: Risk Control Measures and Implementation - Applying the risk control hierarchy: inherent safety, protective measures, information
- Designing out hazards through engineering controls
- Implementing alarms, interlocks, and safeguards
- Failure detection and system diagnostics as risk controls
- Software reliability and redundancy strategies
- Labelling and IFU as a last line of defense
- Determining when risk controls are sufficient
- Linking controls to specific hazards and hazardous situations
- Verification of implemented risk controls
- Documenting rationale for selected control options
- Managing trade-offs between usability and safety
- Design validation of risk controls under real-use conditions
- Integration with design inputs and verification protocols
- Ensuring controls do not introduce new hazards
- Use of safety architectures and fault-tolerant design
Module 6: Risk Management File Structure and Documentation - Complete structure of a risk management file
- ISO 14971 Annex Z compliance checklist
- Creating a risk analysis report with full traceability
- Linking hazards to risk controls in a traceability matrix
- Documenting residual risk and evaluation for acceptability
- Writing comprehensive risk management reports
- Ensuring clarity and consistency across risk documents
- Version control and change management in risk files
- Archiving and retention requirements
- Risk file review and approval processes
- Audit-ready formatting and indexing strategies
- Using tables, diagrams, and annotations effectively
- Summary of benefits versus residual risk
- Handling multiple variants and product families
- Role of risk files in technical documentation for EU MDR
Module 7: Evaluation of Overall Residual Risk - Definition and regulatory expectations for overall residual risk
- Methods for aggregating residual risks across the device
- Role of top management in approving overall residual risk
- Documenting decision rationale with supporting evidence
- Using benefit-risk analysis to justify residual risk
- Incorporating clinical data and risk-benefit evaluation
- Tools for visualising overall residual risk (heat maps, dashboards)
- Presentation formats for management review
- Handling situations where residual risk is not clearly acceptable
- Engaging clinical experts in risk-benefit assessment
- Linking to post-market surveillance planning
- Handling life-sustaining or life-supporting devices
- External review and advisory board involvement
- Documentation required for notified body submissions
- Updating overall residual risk after design changes
Module 8: Risk Management in Design and Development - Integrating risk activities into stage-gate processes
- Risk input into design inputs and specifications
- Using risk to drive design verification and validation
- Risk assessment during prototyping and early testing
- Hazard analysis during design transfer
- Impact of design changes on risk management file
- Change control integration with risk evaluation
- Risk documentation for design history file (DHF)
- Ensuring risk traceability from concept to production
- Use of design reviews for risk validation
- Role of risk in usability testing and formative studies
- Risk assessment of material and supplier changes
- FMEA update during design iterations
- Linking risk to risk-based testing strategies
- Documentation requirements for design freeze and final release
Module 9: Production and Post-Production Risk Activities - Continuity of risk management after design transfer
- Handling nonconformances and CAPA from a risk perspective
- Use of production data to inform risk analysis
- Incorporating supplier nonconformances into risk files
- Risk-based internal audit planning
- Monitoring process deviations for risk impact
- Using field failure data to reassess risk
- Feedback loop from post-market surveillance
- Handling complaints and adverse events as risk inputs
- Software updates and patch management risks
- Service and repair process risk considerations
- Labeling changes and their impact on risk
- Outsourced manufacturing and sterilisation risks
- Managing risk during scale-up and ramp-up phases
- Periodic review of risk management file
Module 10: Risk Management for Software and Connected Devices - Unique hazards in software-based medical devices
- IEC 62304 alignment with ISO 14971
- Risk analysis for software failure modes
- Data integrity, corruption, and transmission risks
- AI and machine learning decision-making risks
- Network and cybersecurity hazards
- Remote monitoring and telehealth risks
- Over-the-air (OTA) update risks
- User authentication and access control failures
- Cloud-based processing and data storage risks
- Latency and connectivity loss scenarios
- Interoperability risks with other systems
- Algorithm drift and performance degradation
- Ensuring software risk controls are validated
- Documentation strategies for software risk files
Module 11: Risk Management for Combination Products and Novel Technologies - Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Systematic approach to hazard identification
- Functional and physical analysis of medical devices
- Using use case analysis to uncover user-related hazards
- FMEA basics applied to medical device risk
- Leveraging clinical data and literature to anticipate hazards
- Input from usability engineering and human factors
- Identifying hazards related to software and AI functionality
- Hazards from accessories, consumables, and ancillary equipment
- Environmental and site-of-use factors (home vs hospital)
- Considering foreseeable misuse and off-label use
- Failure mode analysis: hardware, software, mechanical, electrical
- Chemical and biological hazards from materials
- Service and maintenance-induced hazards
- Labeling and instructions for use as a source of hazard
- Post-market data integration into hazard identification
Module 4: Risk Analysis – Estimating and Evaluating Risk - Determining the probability of occurrence of harm
- Assessing severity of harm: minor, serious, critical, fatal
- Building a risk estimation matrix with consistent scoring
- Quantitative vs qualitative risk estimation approaches
- Incorporating engineering judgment with documented rationale
- Using historical failure data to inform probability estimates
- Factoring in user population vulnerability
- Evaluating risk for combination products and connected devices
- Considering rare but high-severity events
- Documentation of risk estimation rationale for auditors
- Distinguishing between exposure and harm probability
- Estimating risk for software-driven decisions
- Risk evaluation against predefined acceptability criteria
- Handling borderline and subjective risk assessments
- Peer review processes for risk evaluation rigor
Module 5: Risk Control Measures and Implementation - Applying the risk control hierarchy: inherent safety, protective measures, information
- Designing out hazards through engineering controls
- Implementing alarms, interlocks, and safeguards
- Failure detection and system diagnostics as risk controls
- Software reliability and redundancy strategies
- Labelling and IFU as a last line of defense
- Determining when risk controls are sufficient
- Linking controls to specific hazards and hazardous situations
- Verification of implemented risk controls
- Documenting rationale for selected control options
- Managing trade-offs between usability and safety
- Design validation of risk controls under real-use conditions
- Integration with design inputs and verification protocols
- Ensuring controls do not introduce new hazards
- Use of safety architectures and fault-tolerant design
Module 6: Risk Management File Structure and Documentation - Complete structure of a risk management file
- ISO 14971 Annex Z compliance checklist
- Creating a risk analysis report with full traceability
- Linking hazards to risk controls in a traceability matrix
- Documenting residual risk and evaluation for acceptability
- Writing comprehensive risk management reports
- Ensuring clarity and consistency across risk documents
- Version control and change management in risk files
- Archiving and retention requirements
- Risk file review and approval processes
- Audit-ready formatting and indexing strategies
- Using tables, diagrams, and annotations effectively
- Summary of benefits versus residual risk
- Handling multiple variants and product families
- Role of risk files in technical documentation for EU MDR
Module 7: Evaluation of Overall Residual Risk - Definition and regulatory expectations for overall residual risk
- Methods for aggregating residual risks across the device
- Role of top management in approving overall residual risk
- Documenting decision rationale with supporting evidence
- Using benefit-risk analysis to justify residual risk
- Incorporating clinical data and risk-benefit evaluation
- Tools for visualising overall residual risk (heat maps, dashboards)
- Presentation formats for management review
- Handling situations where residual risk is not clearly acceptable
- Engaging clinical experts in risk-benefit assessment
- Linking to post-market surveillance planning
- Handling life-sustaining or life-supporting devices
- External review and advisory board involvement
- Documentation required for notified body submissions
- Updating overall residual risk after design changes
Module 8: Risk Management in Design and Development - Integrating risk activities into stage-gate processes
- Risk input into design inputs and specifications
- Using risk to drive design verification and validation
- Risk assessment during prototyping and early testing
- Hazard analysis during design transfer
- Impact of design changes on risk management file
- Change control integration with risk evaluation
- Risk documentation for design history file (DHF)
- Ensuring risk traceability from concept to production
- Use of design reviews for risk validation
- Role of risk in usability testing and formative studies
- Risk assessment of material and supplier changes
- FMEA update during design iterations
- Linking risk to risk-based testing strategies
- Documentation requirements for design freeze and final release
Module 9: Production and Post-Production Risk Activities - Continuity of risk management after design transfer
- Handling nonconformances and CAPA from a risk perspective
- Use of production data to inform risk analysis
- Incorporating supplier nonconformances into risk files
- Risk-based internal audit planning
- Monitoring process deviations for risk impact
- Using field failure data to reassess risk
- Feedback loop from post-market surveillance
- Handling complaints and adverse events as risk inputs
- Software updates and patch management risks
- Service and repair process risk considerations
- Labeling changes and their impact on risk
- Outsourced manufacturing and sterilisation risks
- Managing risk during scale-up and ramp-up phases
- Periodic review of risk management file
Module 10: Risk Management for Software and Connected Devices - Unique hazards in software-based medical devices
- IEC 62304 alignment with ISO 14971
- Risk analysis for software failure modes
- Data integrity, corruption, and transmission risks
- AI and machine learning decision-making risks
- Network and cybersecurity hazards
- Remote monitoring and telehealth risks
- Over-the-air (OTA) update risks
- User authentication and access control failures
- Cloud-based processing and data storage risks
- Latency and connectivity loss scenarios
- Interoperability risks with other systems
- Algorithm drift and performance degradation
- Ensuring software risk controls are validated
- Documentation strategies for software risk files
Module 11: Risk Management for Combination Products and Novel Technologies - Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Applying the risk control hierarchy: inherent safety, protective measures, information
- Designing out hazards through engineering controls
- Implementing alarms, interlocks, and safeguards
- Failure detection and system diagnostics as risk controls
- Software reliability and redundancy strategies
- Labelling and IFU as a last line of defense
- Determining when risk controls are sufficient
- Linking controls to specific hazards and hazardous situations
- Verification of implemented risk controls
- Documenting rationale for selected control options
- Managing trade-offs between usability and safety
- Design validation of risk controls under real-use conditions
- Integration with design inputs and verification protocols
- Ensuring controls do not introduce new hazards
- Use of safety architectures and fault-tolerant design
Module 6: Risk Management File Structure and Documentation - Complete structure of a risk management file
- ISO 14971 Annex Z compliance checklist
- Creating a risk analysis report with full traceability
- Linking hazards to risk controls in a traceability matrix
- Documenting residual risk and evaluation for acceptability
- Writing comprehensive risk management reports
- Ensuring clarity and consistency across risk documents
- Version control and change management in risk files
- Archiving and retention requirements
- Risk file review and approval processes
- Audit-ready formatting and indexing strategies
- Using tables, diagrams, and annotations effectively
- Summary of benefits versus residual risk
- Handling multiple variants and product families
- Role of risk files in technical documentation for EU MDR
Module 7: Evaluation of Overall Residual Risk - Definition and regulatory expectations for overall residual risk
- Methods for aggregating residual risks across the device
- Role of top management in approving overall residual risk
- Documenting decision rationale with supporting evidence
- Using benefit-risk analysis to justify residual risk
- Incorporating clinical data and risk-benefit evaluation
- Tools for visualising overall residual risk (heat maps, dashboards)
- Presentation formats for management review
- Handling situations where residual risk is not clearly acceptable
- Engaging clinical experts in risk-benefit assessment
- Linking to post-market surveillance planning
- Handling life-sustaining or life-supporting devices
- External review and advisory board involvement
- Documentation required for notified body submissions
- Updating overall residual risk after design changes
Module 8: Risk Management in Design and Development - Integrating risk activities into stage-gate processes
- Risk input into design inputs and specifications
- Using risk to drive design verification and validation
- Risk assessment during prototyping and early testing
- Hazard analysis during design transfer
- Impact of design changes on risk management file
- Change control integration with risk evaluation
- Risk documentation for design history file (DHF)
- Ensuring risk traceability from concept to production
- Use of design reviews for risk validation
- Role of risk in usability testing and formative studies
- Risk assessment of material and supplier changes
- FMEA update during design iterations
- Linking risk to risk-based testing strategies
- Documentation requirements for design freeze and final release
Module 9: Production and Post-Production Risk Activities - Continuity of risk management after design transfer
- Handling nonconformances and CAPA from a risk perspective
- Use of production data to inform risk analysis
- Incorporating supplier nonconformances into risk files
- Risk-based internal audit planning
- Monitoring process deviations for risk impact
- Using field failure data to reassess risk
- Feedback loop from post-market surveillance
- Handling complaints and adverse events as risk inputs
- Software updates and patch management risks
- Service and repair process risk considerations
- Labeling changes and their impact on risk
- Outsourced manufacturing and sterilisation risks
- Managing risk during scale-up and ramp-up phases
- Periodic review of risk management file
Module 10: Risk Management for Software and Connected Devices - Unique hazards in software-based medical devices
- IEC 62304 alignment with ISO 14971
- Risk analysis for software failure modes
- Data integrity, corruption, and transmission risks
- AI and machine learning decision-making risks
- Network and cybersecurity hazards
- Remote monitoring and telehealth risks
- Over-the-air (OTA) update risks
- User authentication and access control failures
- Cloud-based processing and data storage risks
- Latency and connectivity loss scenarios
- Interoperability risks with other systems
- Algorithm drift and performance degradation
- Ensuring software risk controls are validated
- Documentation strategies for software risk files
Module 11: Risk Management for Combination Products and Novel Technologies - Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Definition and regulatory expectations for overall residual risk
- Methods for aggregating residual risks across the device
- Role of top management in approving overall residual risk
- Documenting decision rationale with supporting evidence
- Using benefit-risk analysis to justify residual risk
- Incorporating clinical data and risk-benefit evaluation
- Tools for visualising overall residual risk (heat maps, dashboards)
- Presentation formats for management review
- Handling situations where residual risk is not clearly acceptable
- Engaging clinical experts in risk-benefit assessment
- Linking to post-market surveillance planning
- Handling life-sustaining or life-supporting devices
- External review and advisory board involvement
- Documentation required for notified body submissions
- Updating overall residual risk after design changes
Module 8: Risk Management in Design and Development - Integrating risk activities into stage-gate processes
- Risk input into design inputs and specifications
- Using risk to drive design verification and validation
- Risk assessment during prototyping and early testing
- Hazard analysis during design transfer
- Impact of design changes on risk management file
- Change control integration with risk evaluation
- Risk documentation for design history file (DHF)
- Ensuring risk traceability from concept to production
- Use of design reviews for risk validation
- Role of risk in usability testing and formative studies
- Risk assessment of material and supplier changes
- FMEA update during design iterations
- Linking risk to risk-based testing strategies
- Documentation requirements for design freeze and final release
Module 9: Production and Post-Production Risk Activities - Continuity of risk management after design transfer
- Handling nonconformances and CAPA from a risk perspective
- Use of production data to inform risk analysis
- Incorporating supplier nonconformances into risk files
- Risk-based internal audit planning
- Monitoring process deviations for risk impact
- Using field failure data to reassess risk
- Feedback loop from post-market surveillance
- Handling complaints and adverse events as risk inputs
- Software updates and patch management risks
- Service and repair process risk considerations
- Labeling changes and their impact on risk
- Outsourced manufacturing and sterilisation risks
- Managing risk during scale-up and ramp-up phases
- Periodic review of risk management file
Module 10: Risk Management for Software and Connected Devices - Unique hazards in software-based medical devices
- IEC 62304 alignment with ISO 14971
- Risk analysis for software failure modes
- Data integrity, corruption, and transmission risks
- AI and machine learning decision-making risks
- Network and cybersecurity hazards
- Remote monitoring and telehealth risks
- Over-the-air (OTA) update risks
- User authentication and access control failures
- Cloud-based processing and data storage risks
- Latency and connectivity loss scenarios
- Interoperability risks with other systems
- Algorithm drift and performance degradation
- Ensuring software risk controls are validated
- Documentation strategies for software risk files
Module 11: Risk Management for Combination Products and Novel Technologies - Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Continuity of risk management after design transfer
- Handling nonconformances and CAPA from a risk perspective
- Use of production data to inform risk analysis
- Incorporating supplier nonconformances into risk files
- Risk-based internal audit planning
- Monitoring process deviations for risk impact
- Using field failure data to reassess risk
- Feedback loop from post-market surveillance
- Handling complaints and adverse events as risk inputs
- Software updates and patch management risks
- Service and repair process risk considerations
- Labeling changes and their impact on risk
- Outsourced manufacturing and sterilisation risks
- Managing risk during scale-up and ramp-up phases
- Periodic review of risk management file
Module 10: Risk Management for Software and Connected Devices - Unique hazards in software-based medical devices
- IEC 62304 alignment with ISO 14971
- Risk analysis for software failure modes
- Data integrity, corruption, and transmission risks
- AI and machine learning decision-making risks
- Network and cybersecurity hazards
- Remote monitoring and telehealth risks
- Over-the-air (OTA) update risks
- User authentication and access control failures
- Cloud-based processing and data storage risks
- Latency and connectivity loss scenarios
- Interoperability risks with other systems
- Algorithm drift and performance degradation
- Ensuring software risk controls are validated
- Documentation strategies for software risk files
Module 11: Risk Management for Combination Products and Novel Technologies - Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Defining combination products: drug-device, biologic-device
- Regulatory expectations from multiple agencies (FDA, EMA)
- Shared and unique risks in combination products
- Dosing errors due to integration failures
- Sterility and contamination risks in prefilled devices
- Novel materials and their long-term biocompatibility
- Gene therapy and advanced therapy risks
- 3D-printed medical devices and patient-specific risks
- Nanomaterials and their toxicological hazards
- Wearable and implantable device risks
- Burn, irritation, and long-term tissue reaction risks
- Battery and power management in miniaturised devices
- Wireless energy transfer risks
- Integration with diagnostic data in closed-loop systems
- Risk documentation strategies for first-in-class devices
Module 12: Risk in Clinical Evaluation and Post-Market Surveillance - Linking risk management to clinical evaluation plan (CEP)
- Using clinical data to support risk acceptability
- Identifying new hazards from clinical investigations
- Integrating PMCF data into risk analysis
- How post-market findings trigger risk reassessment
- Reporting field safety corrective actions (FSCA)
- Using literature reviews to update risk profiles
- Signal detection and risk trending analysis
- Epidemiological data in risk evaluation
- Handling off-label use observed in clinical practice
- Advisory committee input for high-risk devices
- Updating risk files based on public health alerts
- Role of registries and long-term outcome studies
- Risk communication to healthcare professionals
- Documentation requirements for periodic safety update reports
Module 13: Risk Management Audits and Regulatory Inspections - Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Preparing for notified body audits on risk management
- Common nonconformities in ISO 14971 audits
- What regulators look for in risk files
- Responses to findings: minor vs major NCs
- Using mock audits to test risk file readiness
- FDA inspection focus on hazard analysis and controls
- Evidence of management review and oversight
- Traceability demonstrations during audits
- Handling auditor questions on residual risk
- Presenting risk-benefit justifications clearly
- Audit trails for risk file changes and approvals
- Best practices for audit interviews and documentation review
- Corrective action planning for risk-related findings
- Audit checklist for risk management file completeness
- Global regulatory differences in audit expectations
Module 14: Advanced Risk Tools and Integration Strategies - HACCP applied to medical device manufacturing
- Fault tree analysis (FTA) for system-level risks
- HAZOP studies for complex devices
- Event tree analysis for failure progression
- Using Bowtie models for visual risk representation
- Integration with enterprise risk management (ERM)
- Leveraging risk data for strategic decision-making
- Risk-based product portfolio planning
- Portfolio-level risk oversight for multi-product companies
- Dashboard reporting for executive risk summaries
- Automating risk data collection and tracking
- Risk KPIs and performance indicators
- Using risk insights to prioritise R&D investment
- Scenario planning for emerging risk threats
- Linking risk to business continuity and crisis management
Module 15: Implementation, Certification and Career Advancement - Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits
- Step-by-step implementation checklist for your organisation
- Customising templates for your device type and class
- Rollout strategies: pilot, phased, or enterprise-wide
- Training your team on the risk management system
- Conducting internal risk management audits
- Preparing for certification: ISO 13485 and ISO 14971 synergy
- How the Certificate of Completion enhances your career
- Skill translation for QA, RA, Clinical, and Engineering roles
- Benchmarking your risk program against industry leaders
- Negotiating promotions and leadership roles with demonstrated expertise
- Building a personal portfolio of risk documentation samples
- Using the course certificate in job applications and LinkedIn
- Access to exclusive graduate resources and updates
- Joining a global network of certified risk professionals
- Next steps: preparing for advanced certifications and audits