Course Format & Delivery Details Learn at Your Own Pace — Instant Access, Lifetime Learning
This premium course, ISO 14971 Mastery: Risk Management for Medical Devices and Future-Proof Compliance, is designed for professionals who demand clarity, control, and career advancement—without compromise. From the moment you enroll, you gain immediate online access to a fully self-paced, on-demand learning experience. There are no fixed schedules, no live sessions to attend, and no deadlines to meet. You progress when and where it works best for you—whether that’s during a commute, between meetings, or after hours. Designed for Fast Results, Built for Long-Term Success
Most learners complete the course within 10 to 14 days by dedicating just 60–90 minutes per session. However, even after just one module, you’ll walk away with actionable insights you can apply immediately—whether it’s improving a risk file, preparing for an audit, or leading a cross-functional team in risk assessment. The knowledge you gain isn’t theoretical; it’s engineered for real-world impact from day one. Lifetime Access — With Every Future Update Included
Your investment includes lifetime access to the full course curriculum, plus all future updates at no additional cost. Regulatory standards evolve. We stay ahead of them. When ISO 14971 or related guidance changes, your access ensures you’re never left behind. You’ll receive automatic updates so your knowledge remains current, relevant, and globally compliant—forever. Trusted by Professionals Worldwide — Accessible 24/7 on Any Device
The course platform is mobile-friendly and fully responsive, meaning you can learn seamlessly on your smartphone, tablet, or desktop—whether you’re at home, in the office, or on-site at a manufacturing facility. With 24/7 global access, your progress is always within reach, wherever your career takes you. Expert Instructor Support Built In
You’re not learning in isolation. Throughout your journey, you’ll have direct access to structured guidance from our team of ISO 14971 and medical device compliance specialists. Whether you’re clarifying terminology, applying a risk estimation method, or interpreting clause 6.5 of the standard, instructor-backed support ensures your questions are answered with precision and depth. Your Achievement, Officially Recognized
Upon successful completion, you’ll earn a prestigious Certificate of Completion issued by The Art of Service. This globally recognized credential signals mastery of ISO 14971 principles and positions you as a trusted authority in medical device risk management. It’s verifiable, professional, and designed to enhance your resume, LinkedIn profile, and internal credibility. Transparent Pricing — No Hidden Fees. Ever.
The price you see is the price you pay—nothing more, nothing less. There are no recurring charges, upsells, or surprise fees. What you’re getting is a complete, one-time investment in your professional capability. Payment Options That Work for You
We accept all major payment methods, including Visa, Mastercard, and PayPal, ensuring a seamless enrollment process regardless of your preferred method. 100% Risk-Free Enrollment — Satisfied or Refunded
We understand that your time is valuable. That’s why we offer a complete satisfaction guarantee. If at any point you feel the course doesn’t meet your expectations, simply reach out within 30 days for a full refund—no questions asked. This is our promise to deliver extraordinary value or return your investment. What to Expect After Enrollment
Once registered, you’ll receive an enrollment confirmation email. Shortly after, once your course materials are fully processed and prepared, your individual access details will be sent separately. This ensures your learning environment is optimally configured for the highest quality experience. “Will This Work for Me?” — We’ve Got You Covered
Whether you're a Quality Assurance Engineer reviewing design inputs, a Regulatory Affairs Specialist preparing for a Notified Body audit, or a Product Development Lead managing a new Class III device submission—this course is structured to deliver clarity, confidence, and compliance certainty. Each module is mapped to real-world applications across roles, ensuring relevance regardless of your specific function. Real Professionals, Real Results: What They’re Saying
- Within a week of completing this course, I led a successful risk management review that resolved a long-standing gap in our post-market surveillance file. My manager called it 'the most thorough risk analysis we’ve ever had.'” — Sarah L., Quality Systems Manager, Germany
- As a new RA professional, I felt overwhelmed by ISO 14971. This course broke it down into logical, digestible steps. I passed my internal audit with zero findings.” — James T., Regulatory Affairs Associate, Canada
- I’ve been in medtech for 12 years, and I still picked up critical insights—especially on risk-benefit analysis and Annex C documentation. It’s rare to find a course that’s both foundational and advanced. — Dr. Elena M., Principal Risk Analyst, Spain
This Course Works Even If:
- You’ve never written a risk management file before
- You're transitioning from another industry and new to medical devices
- You’ve read the standard but still don’t know how to apply it consistently
- You’re under pressure to close a compliance gap before an upcoming audit
- You’re not a native English speaker—our content is structured for clarity, not complexity
Zero Risk. Maximum Confidence.
We’ve eliminated every barrier between you and mastery. No time pressure. No hidden costs. No expiry. No guesswork. Just a structured, proven path to ISO 14971 competence—backed by a global leader in professional training. Your career deserves this level of certainty. Enroll with confidence, knowing you’re protected every step of the way.
Extensive & Detailed Course Curriculum
Module 1: Foundations of ISO 14971 and Medical Device Risk Management - Understanding the Scope and Applicability of ISO 14971
- Key Definitions: Risk, Residual Risk, Benefit, Harm, Hazard
- The Evolution of ISO 14971: From 2007 to Current Edition
- Regulatory Integration: Linking ISO 14971 with FDA, EU MDR, and Other Global Standards
- The Role of Risk Management in the Medical Device Lifecycle
- Stakeholder Expectations: What Auditors, Notified Bodies, and Regulators Look For
- Differentiating Risk Management, Risk Analysis, Risk Evaluation, and Risk Control
- Linking Risk Management to Design and Development Processes
- Understanding the Risk Management File (RMF): Components and Structure
- Common Misconceptions and Pitfalls in Early Risk Planning
- The Role of Top Management in Risk Management Commitment
- Establishing a Risk Management Policy: Templates and Best Practices
- Creating a Risk Management Plan: Step-by-Step Guidance
- Roles and Responsibilities in the Risk Team
- Integration with ISO 13485 and Quality Management Systems
Module 2: The ISO 14971 Risk Management Process Framework - Overview of the ISO 14971 Risk Management Process Flow
- Clause-by-Clause Interpretation: From 4.2 to 8.5
- Detailed Breakdown of the 7-Step Risk Management Process
- Integrating Risk Management into Project Management Systems
- Identifying Critical Phases for Risk Review Gates
- Timing Risk Reviews: Pre-Design Freeze, Post-Validation, and Post-Market
- Documenting the Risk Management Process for Regulatory Scrutiny
- Ensuring Continuity: Risk Management Across Device Generations
- Managing Risk for Multiple Device Variants and Configurations
- Determining the Boundaries of the Analysis: Device, Accessories, and Environment
- Process Mapping: Linking Risk Steps to Development Milestones
- Aligning Risk Management with Stage-Gate Processes
- Using Flowcharts to Visualise the Risk Pathway
- Determining Decision Accountability and Approval Requirements
- Creating an Audit-Ready Risk Management Process Folder
Module 3: Risk Management Plan (RMP) Development and Execution - Components of a Compliant Risk Management Plan
- Drafting a RMP: Objectives, Scope, and Methodology
- Specifying Risk Acceptability Criteria: Qualitative vs. Quantitative
- Linking RMP to Product Requirements and User Needs
- Planning for Risk Control Measures and Verification
- Establishing Roles and Responsibilities in the RMP
- Timeline and Schedule for Risk Review Activities
- Documentation Requirements for RMP Updates
- How to Define the Risk Management Process for Software as a Medical Device (SaMD)
- Incorporating Human Factors and Usability Engineering into the RMP
- Planning for Post-Market Risk Review Cycles
- Managing Risk Management Interfaces with Suppliers and Contract Manufacturers
- Determining the Level of Detail for Different Risk Scenarios
- Review Checklists for RMP Internal Approval
- Linking RMP to Risk Management Review Meetings
Module 4: Systematic Hazard Identification Techniques - Understanding the Three Sources of Hazards: Device, User, Environment
- Hazard Identification in the Design Phase: Proactive Risk Discovery
- Using Boundary Diagrams to Define the Device and Its Interactions
- Creating a Preliminary Hazard List: From Concept to Clinical Use
- Brainstorming Hazards with Cross-Functional Teams
- Using Use Scenarios and User Stories to Uncover Risks
- Linking Harm to Known Device Functions and Interfaces
- Hazard Identification Techniques: HAZOP, FMEA, and Fault Tree Basics
- Differentiating Hazards, Hazardous Situations, and Harm
- Incorporating Historical Data: Field Reports and Literature
- Identifying Hazards in Software-Controlled Devices
- Biocompatibility and Material-Related Hazards
- Sterilisation and Packaging-Related Risk Scenarios
- Manufacturing Process Hazards and Process Failures
- Environmental and Electromagnetic Interference Risks
Module 5: Estimating and Evaluating Risk: Severity and Probability - Understanding the Risk Equation: Severity × Probability
- Defining Severity Levels: Catastrophic, Critical, Moderate, Negligible
- Establishing a Severity Scale: From Patient Death to Annoyance
- Probability and Likelihood: Rare, Unlikely, Occasional, Frequent
- Benchmarking Probability Against Field Data and Industry Standards
- Subjectivity in Risk Estimation: Managing Variability Across Teams
- Using Risk Matrices: Design, Calibration, and Interpretation
- Qualitative vs. Semi-Quantitative Risk Assessment Approaches
- Validating Risk Estimates with Clinical and Preclinical Data
- Addressing Estimation Challenges for Novel or New-Technology Devices
- Documentation Requirements for Risk Estimation
- Risk Evaluation: Determining Acceptability Against Predefined Criteria
- Dealing with Risks That Fall on the Edge of Acceptability
- Escalation Procedures for Unacceptable Risks
- Linking Risk Evaluation to Risk Control Measures
Module 6: Risk Control Strategies and Hierarchy of Controls - Applying the ISO 14971 Hierarchy of Risk Controls
- Primary Risk Control: Design-In inherent Safety
- Secondary Risk Control: Protective Measures (e.g., Sensors, Alarms)
- Tertiary Risk Control: Information for Safety (Labelling, Instructions)
- Residual Risk Assessment: Evaluating Effectiveness of Controls
- Design Verification of Risk Control Measures
- Validation of Risk Control Effectiveness in Simulated Use
- Determining When Risk Is As Low As Reasonably Practicable (ALARP)
- Linking Risk Controls to Mitigation in the Risk Management File
- Handling Situations Where Residual Risk Is Unacceptable
- Alternative Design Approaches to Reduce Risk
- Software-Based Risk Controls: Validation Requirements
- Electrical, Mechanical, and Software Interlocks
- Fail-Safe and Safe State Design Principles
- Upgrading Risk Controls Based on Post-Market Feedback
Module 7: Risk-Benefit Analysis: Justifying Acceptable Risk - When Is a Risk Acceptable? Regulatory and Ethical Foundations
- Understanding Risk-Benefit as a Regulatory Requirement (EU MDR, FDA)
- Defining the Medical Benefit of the Device to the Patient
- Quantifying Benefit: Clinical Outcomes vs. Risk Exposure
- Documenting the Risk-Benefit Rationale in the Technical File
- Presenting Risk-Benefit to Regulatory Submissions and Notified Bodies
- Using Real-World Evidence to Support Benefit Claims
- Considering Vulnerable Populations and Risk Tolerance
- Justifying Higher Residual Risk in Life-Saving Devices
- Updating Risk-Benefit Analysis Post-Market
- Communicating Risk-Benefit to Clinicians and Patients
- Differentiating Risk-Benefit from Risk Acceptability
- Regulatory Expectations by Device Class (I, IIa, IIb, III)
- Interpreting IFU and Labelling Implications
- Linking Benefit Claims to Intended Use and Indications for Use
Module 8: Production and Post-Production Activities (Clause 9) - Why Clause 9 Is Often the Most Audited Section
- Linking Design Controls to Production Processes
- Ensuring Risk Controls Are Maintained During Manufacturing
- Production Monitoring: Identifying Deviations That Introduce Risk
- Post-Production Data Collection: Complaints, Service Reports, and Field Actions
- Feedback Loops: How Post-Market Data Informs Risk Reviews
- Trigger Points for Revisiting the Risk Management File
- Integrating CAPA with Risk Management Processes
- Using Trend Analysis to Detect Emerging Risks
- Reporting Adverse Events to Regulatory Bodies
- Updating the RMF After Corrective and Preventive Actions
- Reviewing Supplier Changes and Component Substitutions
- Handling Device Modifications and Product Lifecycle Extensions
- Validating Updated Risk Controls After Design Changes
- Managing Risk for Legacy Devices in Continued Production
Module 9: Risk Management File (RMF) Structure and Documentation - Core Components of the Risk Management File
- Structure and Organisation: Recommended Index and Folder Layout
- Linking RMF to DHF, DMR, and Technical Documentation
- Creating a Master RMF Table of Contents
- Best Practices for Version Control and Document Control
- Traceability Matrix: Linking Risks to Design Inputs and Verification
- Documenting Risk Analysis Meetings and Team Decisions
- Ensuring Clarity and Consistency in Risk Descriptions
- Justifying Risk Decisions: The Importance of Rationale
- Annex A Documentation: Risk Estimation and Evaluation Records
- Annex B: Information for Safety and Labelling References
- Annex C: Review of Safety-Related Characteristics
- Annex D: Residual Risk and Benefit Evaluation
- Annex E: Risk Management Plan and Review Records
- Creating RMF Audit Trails: Demonstrating Progress and Oversight
Module 10: Applying Risk Management to Software as a Medical Device (SaMD) - Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
Module 1: Foundations of ISO 14971 and Medical Device Risk Management - Understanding the Scope and Applicability of ISO 14971
- Key Definitions: Risk, Residual Risk, Benefit, Harm, Hazard
- The Evolution of ISO 14971: From 2007 to Current Edition
- Regulatory Integration: Linking ISO 14971 with FDA, EU MDR, and Other Global Standards
- The Role of Risk Management in the Medical Device Lifecycle
- Stakeholder Expectations: What Auditors, Notified Bodies, and Regulators Look For
- Differentiating Risk Management, Risk Analysis, Risk Evaluation, and Risk Control
- Linking Risk Management to Design and Development Processes
- Understanding the Risk Management File (RMF): Components and Structure
- Common Misconceptions and Pitfalls in Early Risk Planning
- The Role of Top Management in Risk Management Commitment
- Establishing a Risk Management Policy: Templates and Best Practices
- Creating a Risk Management Plan: Step-by-Step Guidance
- Roles and Responsibilities in the Risk Team
- Integration with ISO 13485 and Quality Management Systems
Module 2: The ISO 14971 Risk Management Process Framework - Overview of the ISO 14971 Risk Management Process Flow
- Clause-by-Clause Interpretation: From 4.2 to 8.5
- Detailed Breakdown of the 7-Step Risk Management Process
- Integrating Risk Management into Project Management Systems
- Identifying Critical Phases for Risk Review Gates
- Timing Risk Reviews: Pre-Design Freeze, Post-Validation, and Post-Market
- Documenting the Risk Management Process for Regulatory Scrutiny
- Ensuring Continuity: Risk Management Across Device Generations
- Managing Risk for Multiple Device Variants and Configurations
- Determining the Boundaries of the Analysis: Device, Accessories, and Environment
- Process Mapping: Linking Risk Steps to Development Milestones
- Aligning Risk Management with Stage-Gate Processes
- Using Flowcharts to Visualise the Risk Pathway
- Determining Decision Accountability and Approval Requirements
- Creating an Audit-Ready Risk Management Process Folder
Module 3: Risk Management Plan (RMP) Development and Execution - Components of a Compliant Risk Management Plan
- Drafting a RMP: Objectives, Scope, and Methodology
- Specifying Risk Acceptability Criteria: Qualitative vs. Quantitative
- Linking RMP to Product Requirements and User Needs
- Planning for Risk Control Measures and Verification
- Establishing Roles and Responsibilities in the RMP
- Timeline and Schedule for Risk Review Activities
- Documentation Requirements for RMP Updates
- How to Define the Risk Management Process for Software as a Medical Device (SaMD)
- Incorporating Human Factors and Usability Engineering into the RMP
- Planning for Post-Market Risk Review Cycles
- Managing Risk Management Interfaces with Suppliers and Contract Manufacturers
- Determining the Level of Detail for Different Risk Scenarios
- Review Checklists for RMP Internal Approval
- Linking RMP to Risk Management Review Meetings
Module 4: Systematic Hazard Identification Techniques - Understanding the Three Sources of Hazards: Device, User, Environment
- Hazard Identification in the Design Phase: Proactive Risk Discovery
- Using Boundary Diagrams to Define the Device and Its Interactions
- Creating a Preliminary Hazard List: From Concept to Clinical Use
- Brainstorming Hazards with Cross-Functional Teams
- Using Use Scenarios and User Stories to Uncover Risks
- Linking Harm to Known Device Functions and Interfaces
- Hazard Identification Techniques: HAZOP, FMEA, and Fault Tree Basics
- Differentiating Hazards, Hazardous Situations, and Harm
- Incorporating Historical Data: Field Reports and Literature
- Identifying Hazards in Software-Controlled Devices
- Biocompatibility and Material-Related Hazards
- Sterilisation and Packaging-Related Risk Scenarios
- Manufacturing Process Hazards and Process Failures
- Environmental and Electromagnetic Interference Risks
Module 5: Estimating and Evaluating Risk: Severity and Probability - Understanding the Risk Equation: Severity × Probability
- Defining Severity Levels: Catastrophic, Critical, Moderate, Negligible
- Establishing a Severity Scale: From Patient Death to Annoyance
- Probability and Likelihood: Rare, Unlikely, Occasional, Frequent
- Benchmarking Probability Against Field Data and Industry Standards
- Subjectivity in Risk Estimation: Managing Variability Across Teams
- Using Risk Matrices: Design, Calibration, and Interpretation
- Qualitative vs. Semi-Quantitative Risk Assessment Approaches
- Validating Risk Estimates with Clinical and Preclinical Data
- Addressing Estimation Challenges for Novel or New-Technology Devices
- Documentation Requirements for Risk Estimation
- Risk Evaluation: Determining Acceptability Against Predefined Criteria
- Dealing with Risks That Fall on the Edge of Acceptability
- Escalation Procedures for Unacceptable Risks
- Linking Risk Evaluation to Risk Control Measures
Module 6: Risk Control Strategies and Hierarchy of Controls - Applying the ISO 14971 Hierarchy of Risk Controls
- Primary Risk Control: Design-In inherent Safety
- Secondary Risk Control: Protective Measures (e.g., Sensors, Alarms)
- Tertiary Risk Control: Information for Safety (Labelling, Instructions)
- Residual Risk Assessment: Evaluating Effectiveness of Controls
- Design Verification of Risk Control Measures
- Validation of Risk Control Effectiveness in Simulated Use
- Determining When Risk Is As Low As Reasonably Practicable (ALARP)
- Linking Risk Controls to Mitigation in the Risk Management File
- Handling Situations Where Residual Risk Is Unacceptable
- Alternative Design Approaches to Reduce Risk
- Software-Based Risk Controls: Validation Requirements
- Electrical, Mechanical, and Software Interlocks
- Fail-Safe and Safe State Design Principles
- Upgrading Risk Controls Based on Post-Market Feedback
Module 7: Risk-Benefit Analysis: Justifying Acceptable Risk - When Is a Risk Acceptable? Regulatory and Ethical Foundations
- Understanding Risk-Benefit as a Regulatory Requirement (EU MDR, FDA)
- Defining the Medical Benefit of the Device to the Patient
- Quantifying Benefit: Clinical Outcomes vs. Risk Exposure
- Documenting the Risk-Benefit Rationale in the Technical File
- Presenting Risk-Benefit to Regulatory Submissions and Notified Bodies
- Using Real-World Evidence to Support Benefit Claims
- Considering Vulnerable Populations and Risk Tolerance
- Justifying Higher Residual Risk in Life-Saving Devices
- Updating Risk-Benefit Analysis Post-Market
- Communicating Risk-Benefit to Clinicians and Patients
- Differentiating Risk-Benefit from Risk Acceptability
- Regulatory Expectations by Device Class (I, IIa, IIb, III)
- Interpreting IFU and Labelling Implications
- Linking Benefit Claims to Intended Use and Indications for Use
Module 8: Production and Post-Production Activities (Clause 9) - Why Clause 9 Is Often the Most Audited Section
- Linking Design Controls to Production Processes
- Ensuring Risk Controls Are Maintained During Manufacturing
- Production Monitoring: Identifying Deviations That Introduce Risk
- Post-Production Data Collection: Complaints, Service Reports, and Field Actions
- Feedback Loops: How Post-Market Data Informs Risk Reviews
- Trigger Points for Revisiting the Risk Management File
- Integrating CAPA with Risk Management Processes
- Using Trend Analysis to Detect Emerging Risks
- Reporting Adverse Events to Regulatory Bodies
- Updating the RMF After Corrective and Preventive Actions
- Reviewing Supplier Changes and Component Substitutions
- Handling Device Modifications and Product Lifecycle Extensions
- Validating Updated Risk Controls After Design Changes
- Managing Risk for Legacy Devices in Continued Production
Module 9: Risk Management File (RMF) Structure and Documentation - Core Components of the Risk Management File
- Structure and Organisation: Recommended Index and Folder Layout
- Linking RMF to DHF, DMR, and Technical Documentation
- Creating a Master RMF Table of Contents
- Best Practices for Version Control and Document Control
- Traceability Matrix: Linking Risks to Design Inputs and Verification
- Documenting Risk Analysis Meetings and Team Decisions
- Ensuring Clarity and Consistency in Risk Descriptions
- Justifying Risk Decisions: The Importance of Rationale
- Annex A Documentation: Risk Estimation and Evaluation Records
- Annex B: Information for Safety and Labelling References
- Annex C: Review of Safety-Related Characteristics
- Annex D: Residual Risk and Benefit Evaluation
- Annex E: Risk Management Plan and Review Records
- Creating RMF Audit Trails: Demonstrating Progress and Oversight
Module 10: Applying Risk Management to Software as a Medical Device (SaMD) - Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Overview of the ISO 14971 Risk Management Process Flow
- Clause-by-Clause Interpretation: From 4.2 to 8.5
- Detailed Breakdown of the 7-Step Risk Management Process
- Integrating Risk Management into Project Management Systems
- Identifying Critical Phases for Risk Review Gates
- Timing Risk Reviews: Pre-Design Freeze, Post-Validation, and Post-Market
- Documenting the Risk Management Process for Regulatory Scrutiny
- Ensuring Continuity: Risk Management Across Device Generations
- Managing Risk for Multiple Device Variants and Configurations
- Determining the Boundaries of the Analysis: Device, Accessories, and Environment
- Process Mapping: Linking Risk Steps to Development Milestones
- Aligning Risk Management with Stage-Gate Processes
- Using Flowcharts to Visualise the Risk Pathway
- Determining Decision Accountability and Approval Requirements
- Creating an Audit-Ready Risk Management Process Folder
Module 3: Risk Management Plan (RMP) Development and Execution - Components of a Compliant Risk Management Plan
- Drafting a RMP: Objectives, Scope, and Methodology
- Specifying Risk Acceptability Criteria: Qualitative vs. Quantitative
- Linking RMP to Product Requirements and User Needs
- Planning for Risk Control Measures and Verification
- Establishing Roles and Responsibilities in the RMP
- Timeline and Schedule for Risk Review Activities
- Documentation Requirements for RMP Updates
- How to Define the Risk Management Process for Software as a Medical Device (SaMD)
- Incorporating Human Factors and Usability Engineering into the RMP
- Planning for Post-Market Risk Review Cycles
- Managing Risk Management Interfaces with Suppliers and Contract Manufacturers
- Determining the Level of Detail for Different Risk Scenarios
- Review Checklists for RMP Internal Approval
- Linking RMP to Risk Management Review Meetings
Module 4: Systematic Hazard Identification Techniques - Understanding the Three Sources of Hazards: Device, User, Environment
- Hazard Identification in the Design Phase: Proactive Risk Discovery
- Using Boundary Diagrams to Define the Device and Its Interactions
- Creating a Preliminary Hazard List: From Concept to Clinical Use
- Brainstorming Hazards with Cross-Functional Teams
- Using Use Scenarios and User Stories to Uncover Risks
- Linking Harm to Known Device Functions and Interfaces
- Hazard Identification Techniques: HAZOP, FMEA, and Fault Tree Basics
- Differentiating Hazards, Hazardous Situations, and Harm
- Incorporating Historical Data: Field Reports and Literature
- Identifying Hazards in Software-Controlled Devices
- Biocompatibility and Material-Related Hazards
- Sterilisation and Packaging-Related Risk Scenarios
- Manufacturing Process Hazards and Process Failures
- Environmental and Electromagnetic Interference Risks
Module 5: Estimating and Evaluating Risk: Severity and Probability - Understanding the Risk Equation: Severity × Probability
- Defining Severity Levels: Catastrophic, Critical, Moderate, Negligible
- Establishing a Severity Scale: From Patient Death to Annoyance
- Probability and Likelihood: Rare, Unlikely, Occasional, Frequent
- Benchmarking Probability Against Field Data and Industry Standards
- Subjectivity in Risk Estimation: Managing Variability Across Teams
- Using Risk Matrices: Design, Calibration, and Interpretation
- Qualitative vs. Semi-Quantitative Risk Assessment Approaches
- Validating Risk Estimates with Clinical and Preclinical Data
- Addressing Estimation Challenges for Novel or New-Technology Devices
- Documentation Requirements for Risk Estimation
- Risk Evaluation: Determining Acceptability Against Predefined Criteria
- Dealing with Risks That Fall on the Edge of Acceptability
- Escalation Procedures for Unacceptable Risks
- Linking Risk Evaluation to Risk Control Measures
Module 6: Risk Control Strategies and Hierarchy of Controls - Applying the ISO 14971 Hierarchy of Risk Controls
- Primary Risk Control: Design-In inherent Safety
- Secondary Risk Control: Protective Measures (e.g., Sensors, Alarms)
- Tertiary Risk Control: Information for Safety (Labelling, Instructions)
- Residual Risk Assessment: Evaluating Effectiveness of Controls
- Design Verification of Risk Control Measures
- Validation of Risk Control Effectiveness in Simulated Use
- Determining When Risk Is As Low As Reasonably Practicable (ALARP)
- Linking Risk Controls to Mitigation in the Risk Management File
- Handling Situations Where Residual Risk Is Unacceptable
- Alternative Design Approaches to Reduce Risk
- Software-Based Risk Controls: Validation Requirements
- Electrical, Mechanical, and Software Interlocks
- Fail-Safe and Safe State Design Principles
- Upgrading Risk Controls Based on Post-Market Feedback
Module 7: Risk-Benefit Analysis: Justifying Acceptable Risk - When Is a Risk Acceptable? Regulatory and Ethical Foundations
- Understanding Risk-Benefit as a Regulatory Requirement (EU MDR, FDA)
- Defining the Medical Benefit of the Device to the Patient
- Quantifying Benefit: Clinical Outcomes vs. Risk Exposure
- Documenting the Risk-Benefit Rationale in the Technical File
- Presenting Risk-Benefit to Regulatory Submissions and Notified Bodies
- Using Real-World Evidence to Support Benefit Claims
- Considering Vulnerable Populations and Risk Tolerance
- Justifying Higher Residual Risk in Life-Saving Devices
- Updating Risk-Benefit Analysis Post-Market
- Communicating Risk-Benefit to Clinicians and Patients
- Differentiating Risk-Benefit from Risk Acceptability
- Regulatory Expectations by Device Class (I, IIa, IIb, III)
- Interpreting IFU and Labelling Implications
- Linking Benefit Claims to Intended Use and Indications for Use
Module 8: Production and Post-Production Activities (Clause 9) - Why Clause 9 Is Often the Most Audited Section
- Linking Design Controls to Production Processes
- Ensuring Risk Controls Are Maintained During Manufacturing
- Production Monitoring: Identifying Deviations That Introduce Risk
- Post-Production Data Collection: Complaints, Service Reports, and Field Actions
- Feedback Loops: How Post-Market Data Informs Risk Reviews
- Trigger Points for Revisiting the Risk Management File
- Integrating CAPA with Risk Management Processes
- Using Trend Analysis to Detect Emerging Risks
- Reporting Adverse Events to Regulatory Bodies
- Updating the RMF After Corrective and Preventive Actions
- Reviewing Supplier Changes and Component Substitutions
- Handling Device Modifications and Product Lifecycle Extensions
- Validating Updated Risk Controls After Design Changes
- Managing Risk for Legacy Devices in Continued Production
Module 9: Risk Management File (RMF) Structure and Documentation - Core Components of the Risk Management File
- Structure and Organisation: Recommended Index and Folder Layout
- Linking RMF to DHF, DMR, and Technical Documentation
- Creating a Master RMF Table of Contents
- Best Practices for Version Control and Document Control
- Traceability Matrix: Linking Risks to Design Inputs and Verification
- Documenting Risk Analysis Meetings and Team Decisions
- Ensuring Clarity and Consistency in Risk Descriptions
- Justifying Risk Decisions: The Importance of Rationale
- Annex A Documentation: Risk Estimation and Evaluation Records
- Annex B: Information for Safety and Labelling References
- Annex C: Review of Safety-Related Characteristics
- Annex D: Residual Risk and Benefit Evaluation
- Annex E: Risk Management Plan and Review Records
- Creating RMF Audit Trails: Demonstrating Progress and Oversight
Module 10: Applying Risk Management to Software as a Medical Device (SaMD) - Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Understanding the Three Sources of Hazards: Device, User, Environment
- Hazard Identification in the Design Phase: Proactive Risk Discovery
- Using Boundary Diagrams to Define the Device and Its Interactions
- Creating a Preliminary Hazard List: From Concept to Clinical Use
- Brainstorming Hazards with Cross-Functional Teams
- Using Use Scenarios and User Stories to Uncover Risks
- Linking Harm to Known Device Functions and Interfaces
- Hazard Identification Techniques: HAZOP, FMEA, and Fault Tree Basics
- Differentiating Hazards, Hazardous Situations, and Harm
- Incorporating Historical Data: Field Reports and Literature
- Identifying Hazards in Software-Controlled Devices
- Biocompatibility and Material-Related Hazards
- Sterilisation and Packaging-Related Risk Scenarios
- Manufacturing Process Hazards and Process Failures
- Environmental and Electromagnetic Interference Risks
Module 5: Estimating and Evaluating Risk: Severity and Probability - Understanding the Risk Equation: Severity × Probability
- Defining Severity Levels: Catastrophic, Critical, Moderate, Negligible
- Establishing a Severity Scale: From Patient Death to Annoyance
- Probability and Likelihood: Rare, Unlikely, Occasional, Frequent
- Benchmarking Probability Against Field Data and Industry Standards
- Subjectivity in Risk Estimation: Managing Variability Across Teams
- Using Risk Matrices: Design, Calibration, and Interpretation
- Qualitative vs. Semi-Quantitative Risk Assessment Approaches
- Validating Risk Estimates with Clinical and Preclinical Data
- Addressing Estimation Challenges for Novel or New-Technology Devices
- Documentation Requirements for Risk Estimation
- Risk Evaluation: Determining Acceptability Against Predefined Criteria
- Dealing with Risks That Fall on the Edge of Acceptability
- Escalation Procedures for Unacceptable Risks
- Linking Risk Evaluation to Risk Control Measures
Module 6: Risk Control Strategies and Hierarchy of Controls - Applying the ISO 14971 Hierarchy of Risk Controls
- Primary Risk Control: Design-In inherent Safety
- Secondary Risk Control: Protective Measures (e.g., Sensors, Alarms)
- Tertiary Risk Control: Information for Safety (Labelling, Instructions)
- Residual Risk Assessment: Evaluating Effectiveness of Controls
- Design Verification of Risk Control Measures
- Validation of Risk Control Effectiveness in Simulated Use
- Determining When Risk Is As Low As Reasonably Practicable (ALARP)
- Linking Risk Controls to Mitigation in the Risk Management File
- Handling Situations Where Residual Risk Is Unacceptable
- Alternative Design Approaches to Reduce Risk
- Software-Based Risk Controls: Validation Requirements
- Electrical, Mechanical, and Software Interlocks
- Fail-Safe and Safe State Design Principles
- Upgrading Risk Controls Based on Post-Market Feedback
Module 7: Risk-Benefit Analysis: Justifying Acceptable Risk - When Is a Risk Acceptable? Regulatory and Ethical Foundations
- Understanding Risk-Benefit as a Regulatory Requirement (EU MDR, FDA)
- Defining the Medical Benefit of the Device to the Patient
- Quantifying Benefit: Clinical Outcomes vs. Risk Exposure
- Documenting the Risk-Benefit Rationale in the Technical File
- Presenting Risk-Benefit to Regulatory Submissions and Notified Bodies
- Using Real-World Evidence to Support Benefit Claims
- Considering Vulnerable Populations and Risk Tolerance
- Justifying Higher Residual Risk in Life-Saving Devices
- Updating Risk-Benefit Analysis Post-Market
- Communicating Risk-Benefit to Clinicians and Patients
- Differentiating Risk-Benefit from Risk Acceptability
- Regulatory Expectations by Device Class (I, IIa, IIb, III)
- Interpreting IFU and Labelling Implications
- Linking Benefit Claims to Intended Use and Indications for Use
Module 8: Production and Post-Production Activities (Clause 9) - Why Clause 9 Is Often the Most Audited Section
- Linking Design Controls to Production Processes
- Ensuring Risk Controls Are Maintained During Manufacturing
- Production Monitoring: Identifying Deviations That Introduce Risk
- Post-Production Data Collection: Complaints, Service Reports, and Field Actions
- Feedback Loops: How Post-Market Data Informs Risk Reviews
- Trigger Points for Revisiting the Risk Management File
- Integrating CAPA with Risk Management Processes
- Using Trend Analysis to Detect Emerging Risks
- Reporting Adverse Events to Regulatory Bodies
- Updating the RMF After Corrective and Preventive Actions
- Reviewing Supplier Changes and Component Substitutions
- Handling Device Modifications and Product Lifecycle Extensions
- Validating Updated Risk Controls After Design Changes
- Managing Risk for Legacy Devices in Continued Production
Module 9: Risk Management File (RMF) Structure and Documentation - Core Components of the Risk Management File
- Structure and Organisation: Recommended Index and Folder Layout
- Linking RMF to DHF, DMR, and Technical Documentation
- Creating a Master RMF Table of Contents
- Best Practices for Version Control and Document Control
- Traceability Matrix: Linking Risks to Design Inputs and Verification
- Documenting Risk Analysis Meetings and Team Decisions
- Ensuring Clarity and Consistency in Risk Descriptions
- Justifying Risk Decisions: The Importance of Rationale
- Annex A Documentation: Risk Estimation and Evaluation Records
- Annex B: Information for Safety and Labelling References
- Annex C: Review of Safety-Related Characteristics
- Annex D: Residual Risk and Benefit Evaluation
- Annex E: Risk Management Plan and Review Records
- Creating RMF Audit Trails: Demonstrating Progress and Oversight
Module 10: Applying Risk Management to Software as a Medical Device (SaMD) - Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Applying the ISO 14971 Hierarchy of Risk Controls
- Primary Risk Control: Design-In inherent Safety
- Secondary Risk Control: Protective Measures (e.g., Sensors, Alarms)
- Tertiary Risk Control: Information for Safety (Labelling, Instructions)
- Residual Risk Assessment: Evaluating Effectiveness of Controls
- Design Verification of Risk Control Measures
- Validation of Risk Control Effectiveness in Simulated Use
- Determining When Risk Is As Low As Reasonably Practicable (ALARP)
- Linking Risk Controls to Mitigation in the Risk Management File
- Handling Situations Where Residual Risk Is Unacceptable
- Alternative Design Approaches to Reduce Risk
- Software-Based Risk Controls: Validation Requirements
- Electrical, Mechanical, and Software Interlocks
- Fail-Safe and Safe State Design Principles
- Upgrading Risk Controls Based on Post-Market Feedback
Module 7: Risk-Benefit Analysis: Justifying Acceptable Risk - When Is a Risk Acceptable? Regulatory and Ethical Foundations
- Understanding Risk-Benefit as a Regulatory Requirement (EU MDR, FDA)
- Defining the Medical Benefit of the Device to the Patient
- Quantifying Benefit: Clinical Outcomes vs. Risk Exposure
- Documenting the Risk-Benefit Rationale in the Technical File
- Presenting Risk-Benefit to Regulatory Submissions and Notified Bodies
- Using Real-World Evidence to Support Benefit Claims
- Considering Vulnerable Populations and Risk Tolerance
- Justifying Higher Residual Risk in Life-Saving Devices
- Updating Risk-Benefit Analysis Post-Market
- Communicating Risk-Benefit to Clinicians and Patients
- Differentiating Risk-Benefit from Risk Acceptability
- Regulatory Expectations by Device Class (I, IIa, IIb, III)
- Interpreting IFU and Labelling Implications
- Linking Benefit Claims to Intended Use and Indications for Use
Module 8: Production and Post-Production Activities (Clause 9) - Why Clause 9 Is Often the Most Audited Section
- Linking Design Controls to Production Processes
- Ensuring Risk Controls Are Maintained During Manufacturing
- Production Monitoring: Identifying Deviations That Introduce Risk
- Post-Production Data Collection: Complaints, Service Reports, and Field Actions
- Feedback Loops: How Post-Market Data Informs Risk Reviews
- Trigger Points for Revisiting the Risk Management File
- Integrating CAPA with Risk Management Processes
- Using Trend Analysis to Detect Emerging Risks
- Reporting Adverse Events to Regulatory Bodies
- Updating the RMF After Corrective and Preventive Actions
- Reviewing Supplier Changes and Component Substitutions
- Handling Device Modifications and Product Lifecycle Extensions
- Validating Updated Risk Controls After Design Changes
- Managing Risk for Legacy Devices in Continued Production
Module 9: Risk Management File (RMF) Structure and Documentation - Core Components of the Risk Management File
- Structure and Organisation: Recommended Index and Folder Layout
- Linking RMF to DHF, DMR, and Technical Documentation
- Creating a Master RMF Table of Contents
- Best Practices for Version Control and Document Control
- Traceability Matrix: Linking Risks to Design Inputs and Verification
- Documenting Risk Analysis Meetings and Team Decisions
- Ensuring Clarity and Consistency in Risk Descriptions
- Justifying Risk Decisions: The Importance of Rationale
- Annex A Documentation: Risk Estimation and Evaluation Records
- Annex B: Information for Safety and Labelling References
- Annex C: Review of Safety-Related Characteristics
- Annex D: Residual Risk and Benefit Evaluation
- Annex E: Risk Management Plan and Review Records
- Creating RMF Audit Trails: Demonstrating Progress and Oversight
Module 10: Applying Risk Management to Software as a Medical Device (SaMD) - Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Why Clause 9 Is Often the Most Audited Section
- Linking Design Controls to Production Processes
- Ensuring Risk Controls Are Maintained During Manufacturing
- Production Monitoring: Identifying Deviations That Introduce Risk
- Post-Production Data Collection: Complaints, Service Reports, and Field Actions
- Feedback Loops: How Post-Market Data Informs Risk Reviews
- Trigger Points for Revisiting the Risk Management File
- Integrating CAPA with Risk Management Processes
- Using Trend Analysis to Detect Emerging Risks
- Reporting Adverse Events to Regulatory Bodies
- Updating the RMF After Corrective and Preventive Actions
- Reviewing Supplier Changes and Component Substitutions
- Handling Device Modifications and Product Lifecycle Extensions
- Validating Updated Risk Controls After Design Changes
- Managing Risk for Legacy Devices in Continued Production
Module 9: Risk Management File (RMF) Structure and Documentation - Core Components of the Risk Management File
- Structure and Organisation: Recommended Index and Folder Layout
- Linking RMF to DHF, DMR, and Technical Documentation
- Creating a Master RMF Table of Contents
- Best Practices for Version Control and Document Control
- Traceability Matrix: Linking Risks to Design Inputs and Verification
- Documenting Risk Analysis Meetings and Team Decisions
- Ensuring Clarity and Consistency in Risk Descriptions
- Justifying Risk Decisions: The Importance of Rationale
- Annex A Documentation: Risk Estimation and Evaluation Records
- Annex B: Information for Safety and Labelling References
- Annex C: Review of Safety-Related Characteristics
- Annex D: Residual Risk and Benefit Evaluation
- Annex E: Risk Management Plan and Review Records
- Creating RMF Audit Trails: Demonstrating Progress and Oversight
Module 10: Applying Risk Management to Software as a Medical Device (SaMD) - Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Unique Risks in Software-Controlled and Connected Devices
- Differentiating Calculated Risk from Hardware Risk
- Using IEC 62304 to Inform SaMD Risk Analysis
- Hazard Classes for SaMD: A, B, and C
- Software Failure Modes: Algorithm Errors, Data Corruption, Crash Scenarios
- Network and Cybersecurity-Related Risk Considerations
- Remote Monitoring and Cloud-Based Risk Implications
- Over-the-Air (OTA) Updates and Associated Risk
- Artificial Intelligence and Machine Learning Bias Risk
- Human-Computer Interaction and Alert Fatigue
- Fail-Safe States in Software Systems
- Validation of Software Risk Controls: Unit Testing, Integration, UAT
- Traceability from Software Requirements to Risk Controls
- Logging and Error Reporting for Risk Monitoring
- Documenting SaMD Risk in the Overall RMF
Module 11: Integration with Human Factors and Usability Engineering - Linking ISO 14971 with IEC 62366-1 Requirements
- Defining Use Errors as Hazards in Risk Analysis
- Intended Use vs. Reasonably Foreseeable Misuse
- Hazardous Situations from Poor User Interface Design
- Bridging the Gap Between Risk Analysts and Usability Engineers
- Using Summative Testing to Identify Residual Risk
- Factors That Contribute to Use Error: Stress, Environment, Training
- Labeling, Icons, and On-Device Instructions as Risk Controls
- Simulating Clinical Use to Uncover Hidden Hazards
- Training as a Risk Control Measure: Limitations and Risks
- Designing for Intuitive Use: Reducing Cognitive Load
- Alarms and Audible Indicators in Risk Mitigation
- Integration of Usability Findings into the Risk Management Process
- Updating Risk Files After Human Factors Studies
- Presenting Combined Risk and Usability Evidence to Regulators
Module 12: Risk Management for Combination Products and Drug-Delivery Devices - Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Challenges in Hybrid Product Risk Management
- Coordinating Risk Assessments Between Drug and Device Portfolios
- Identifying Hazards from Drug-Device Interaction
- Device-Related Risks in Single-Use Injectors and Pens
- Dose Accuracy and Delivery Mechanism Risk
- Contamination and Sterility Risks in Combination Systems
- Software Interactions in Smart Injectors
- Aligning Risk Acceptability Between Regulatory Paths (FDA CDER vs. CDRH)
- Labelling Risks: Confusion Between Drug and Device Instructions
- Environmental and Storage Condition Risks
- Patient Training and Adherence Risks
- Bridging Preclinical and Clinical Risk Data
- Post-Market Surveillance for Multi-Component Systems
- Design Verification of Drug-Device Interface
- Supplier Control in Dual-Sourced Products
Module 13: Risk Management in Design and Development - Integrating Risk Management into Design Controls
- Conducting Risk Reviews at Design Inputs
- Translation of Risk Inputs into Design Outputs
- Risk-Driven Design Verification and Validation
- Using Risk Files to Support Design FMEA
- Design Freeze and Risk Closure Points
- Risk Assessment of Protoypes and Early Models
- Managing Risk During Design Iterations
- Change Control and Risk Reassessment
- Vendor-Driven Design Changes and Risk Impact
- Material Selection and Biocompatibility Risk Integration
- Accelerated Life Testing and Risk Correlation
- Reliability Engineering and Risk Estimation
- Design Margin and Safety Factor Analysis
- Ensuring Risk Documentation Supports 510(k) or PMA Submissions
Module 14: Risk Management in Clinical and Post-Market Surveillance - Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Using Clinical Data to Validate Risk Controls
- Incorporating Clinical Investigations into Risk Evaluation
- Monitoring Risk in Real-World Use Environments
- Identifying Post-Market Hazards from Patient Data
- Complaint Triage and Risk Prioritisation
- Field Safety Corrective Actions and Risk Re-evaluation
- Periodic Risk Evaluation Reports (PRERs)
- Requirements Under EU MDR for Periodic Safety Update Reports (PSURs)
- Signal Detection and Risk Trigger Analysis
- Feedback Loops from Service and Repair Data
- Recalls and Risk Management Implications
- Monitoring Social Media and Real-World Feedback for Risk Signals
- Global Pharmacovigilance and Vigilance Systems
- Updating Risk Documentation Based on Real-World Evidence
- Presenting Post-Market Risk Updates to Notified Bodies
Module 15: Advanced Risk Tools and Techniques - Failure Mode and Effects Analysis (FMEA) — Full Walkthrough
- Difference Between Design and Process FMEA
- Applying Fault Tree Analysis (FTA) to Complex Systems
- Preliminary Hazard Analysis (PHA) in Early Development
- HAZOP Studies for Complex Medical Equipment
- Event Tree Analysis for Scenario Modelling
- Human Error Probability Assessment
- Using Decision Trees in Risk Evaluation
- Monte Carlo Simulation for Estimating Risk Distributions
- Bayesian Methods for Updating Risk Probabilities
- Integration of AI-Based Predictive Risk Analytics
- Creating Risk Heat Maps and Visual Dashboards
- Facilitating Risk Workshops and Facilitated Meetings
- Using Checklists to Standardise Risk Assessments Across Teams
- Metrics and KPIs for Measuring Risk Management Maturity
Module 16: Risk Management Review, Certification, and Your Next Steps - Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971
- Conducting Effective Risk Management Review Meetings
- Review Frequency Based on Device Class and Risk Profile
- Inputs Required for a Compliance-Ready Review
- Preparing Audit-Ready Review Documentation
- Presenting Risk Updates to Management and Regulators
- Leveraging Your Certificate of Completion for Career Growth
- Adding the Credential to LinkedIn and Professional Profiles
- Using Your New Skills in Internal Audits and Risk Leadership
- Adapting ISO 14971 Principles to Other Standards (e.g., ISO 13485, IEC 60601)
- Next-Level Learning Pathways: Regulatory Strategy, Quality Auditing, and More
- Joining Professional Networks and Communities of Practice
- How to Mentor Others in Risk Management Best Practices
- Maintaining Your Knowledge with Lifetime Access and Updates
- Progress Tracking and Goal Setting in Your Learning Journey
- Celebrating Your Achievement: You’ve Mastered ISO 14971