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Risk Management for Medical Devices ISO 14971:2019 Course & Certification
Intermediate
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About
Risk Management for Medical Devices ISO 14971:2019 is a comprehensive program designed to help professionals understand, implement, and maintain an effective risk management system throughout the medical device lifecycle. The course is based on ISO 14971:2019 and covers risk identification, evaluation, control, residual risk assessment, post-market surveillance, and integration with quality management systems.
This Risk Management for Medical Devices ISO 14971:2019 Course & Certification provides practical training in risk analysis methodologies, 5×5 risk matrices, risk management planning, FMEA, risk-benefit analysis, residual risk evaluation, and risk management reporting. Participants learn how to identify hazards, implement risk controls, document risk management activities, and maintain compliance with international medical device regulatory expectations. Upon completion, learners receive certification demonstrating competency in medical device risk management principles and ISO 14971 requirements.
Who Should Enrol?
- Medical Device Quality Assurance, Quality Management, and Regulatory Affairs Professionals.
- Risk Management Specialists, Product Safety Professionals, and Compliance Teams.
- Medical Device Design, Development, Engineering, and Manufacturing Personnel.
- Clinical Affairs, Post-Market Surveillance, and Quality Systems Professionals.
- Entry-level professionals and consultants seeking ISO 14971 certification and expertise in medical device risk management.
What you will learn
Understand ISO 14971:2019 requirements, risk management principles, hazard identification, risk evaluation, and the use of 5×5 risk matrices for medical devices.
Learn how to develop Risk Management Plans, Risk Management Files, risk acceptability criteria, and implement effective risk control and mitigation strategies.
Develop expertise in Failure Modes and Effects Analysis (FMEA), Risk Priority Number (RPN) calculations, and integrating risk analysis tools into the risk management process.
Gain knowledge of risk-benefit analysis, residual risk evaluation, post-market surveillance, risk management reporting, and integration with Quality Management Systems (QMS).
Course Syllabus
- Understanding Risk in Medical Devices
- Hazard, Harm & Risk: Worked Example
- Introduction to the 5×5 Risk Matrix
- The 5×5 Matrix: Probability Scale
- The 5×5 Matrix: Severity Scale
- Reading and Interpreting the 5×5 Matrix
- Case Study: 5×5 Matrix in Practice
- Risk Acceptability Criteria
- What Is a Risk Management Policy?
- Key Elements of a Risk Management Policy
- Building Your Risk Management Policy
- Risk Mitigation: Overview
- Hierarchy of Risk Controls (ISO 14971 Clause 6.2)
- The ISO 14971 Risk Management Process
- Stage 1: Risk Analysis (ISO 14971 Clause 4)
- Identifying Hazards and Hazardous Situations
- Stage 2: Risk Evaluation (ISO 14971 Clause 5)
- Stage 3: Risk Control (ISO 14971 Clause 6)
- Stage 4: Residual Risk Evaluation (Clause 7)
- What Is a Risk Management Plan?
- Key Elements of a Risk Management Plan
- RMP: Responsibilities & Roles
- RMP: Criteria for Risk Acceptability
- The Risk Management File
- Verification Activities in Risk Management
- Post-Market Feedback & Risk Management
- RMP: Scope Definition
- Stage 5: Risk Management Report Overview
- What Is FMEA?
- Types of FMEA Used in Medical Devices
- FMEA: Key Components
- FMEA: Step-by-Step Process
- FMEA: Severity Rating Scale
- FMEA: Occurrence Rating Scale
- FMEA: Detection Rating Scale
- Risk Priority Number (RPN)
- FMEA Worksheet Structure
- Design FMEA (dFMEA)
- Process FMEA (pFMEA)
- Case Study: FMEA for an Infusion Pump
- FMEA: Best Practices
- Integrating FMEA into the ISO 14971 Framework
- Risk-Benefit Analysis: Introduction
- Risk-Benefit Analysis Process
- Assessing Overall Residual Risk
- Risk Management in Production Activities
- Post-Production Activities & Risk Management
- Post-Market Surveillance System
- Risk Management and the Quality Management System
- How Risk Management Impacts QMS
- Components of a Risk Management Report
- Writing an Effective Risk Management Report
- Risk Traceability Matrix
- Key Takeaways
- Course Summary
- GLOSSARY
- Glossary of Key Terms (A–R)
- Glossary of Key Terms (R–Z)
- Completion slide
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Frequently Asked Questions
The Risk Management for Medical Devices ISO 14971:2019 course provides a comprehensive foundation for understanding the international standard for risk management in medical devices. It covers the entire product lifecycle, including risk management planning, hazard identification, risk analysis, evaluation, and implementation of risk control measures. Key focus areas include inherently safe design, protective measures, information for safety, residual risk evaluation, and benefit-risk analysis. The course emphasizes the creation and maintenance of the risk management file, post-production information collection, and continuous risk monitoring. Aligned with global regulatory expectations, it equips professionals with practical knowledge to ensure product safety, regulatory compliance, and effective risk management throughout the device lifecycle.
- Overview of ISO 14971:2019 risk management framework for medical devices
- Risk management planning and development of a risk management plan
- Hazard identification, risk analysis, and risk evaluation methodologies
- Implementation of risk control measures: inherently safe design, protective measures, and information for safety
- Residual risk evaluation and benefit-risk analysis
- Risk management file structure and documentation requirements
- Post-production information collection and continuous risk monitoring
- Regulatory expectations and integration of risk management across the product lifecycle
This course is ideal for professionals involved in the design, development, risk management, and regulatory compliance of medical devices, including:
- Regulatory Affairs and Quality Assurance professionals
- Risk management and product safety specialists
- Design and development engineers
- Clinical, safety, and post-market surveillance teams
- Consultants and professionals working with notified bodies
- Anyone seeking to understand ISO 14971:2019 requirements for medical device risk management
- Comprehensive coverage of ISO 14971:2019 requirements for medical device risk management
- Clear understanding of risk analysis, evaluation, control, and lifecycle risk management
- Practical guidance on implementing effective risk control measures and documentation
- Insights into residual risk evaluation and benefit-risk analysis
- Supports regulatory compliance and audit readiness across global markets
- Certificate issued upon successful completion
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