Course Overview

Ensuring the safety, effectiveness, and regulatory compliance of medical devices requires a structured and systematic approach to risk management. From product design and development through production, distribution, and post-market activities, manufacturers must identify potential hazards, evaluate associated risks, and implement appropriate control measures to protect patients, users, and organisations.

The ISO 14971:2019 Risk Management for Medical Devices programme by TransforMentors Academy provides participants with a comprehensive understanding of the internationally recognised framework for medical device risk management. The course explores the principles, requirements, and practical application of ISO 14971:2019, including hazard identification, risk analysis, risk evaluation, risk control, and post-market risk monitoring.

Through practical exercises, real-world case studies, and industry best practices, participants will develop the skills required to establish, implement, and maintain effective risk management processes that support product safety, regulatory compliance, and continual improvement throughout the medical device lifecycle.

Agenda

Day — 1 Introduction to ISO 14971:2019

• Overview of ISO 14971:2019 and Its Importance in Medical Device Safety
• Scope, Purpose, and Key Requirements of ISO 14971:2019
• Structure and Main Clauses of the Standard
• Regulatory Frameworks and Standards Related to Medical Device Risk Management
• Risk Management Process Throughout the Medical Device Lifecycle
• Roles and Responsibilities of Risk Managers and Key Stakeholders
• Fundamentals of Risk Management Planning and Documentation

Day — 2 Risk Analysis and Hazard Identification

• Types of Risks and Hazards Associated with Medical Devices
• Hazard Identification Methods Across the Medical Device Lifecycle:
  • Design and Development
  • Manufacturing and Production
  • Device Use and User Interaction
• Risk Analysis Techniques:
  • Preliminary Hazard Analysis (PHA)
  • Fault Tree Analysis (FTA)
  • Failure Modes and Effects Analysis (FMEA)
• Risk Evaluation Criteria and Requirements Under ISO 14971:2019
• Qualitative, Quantitative, and Semi-Quantitative Risk Estimation Approaches
• Assessing Risk Severity, Probability, and Acceptability
• Documenting Risk Analysis Results and Supporting Evidence

Day — 3 Risk Control and Evaluation for Medical Devices

• Principles and Hierarchy of Risk Control Measures
• Selecting and Implementing Effective Risk Control Strategies
• Verification and Validation of Risk Control Measures
• Residual Risk Evaluation and Assessment Techniques
• Benefit-Risk Analysis for Medical Device Safety Decisions
• Establishing and Applying Risk Acceptability Criteria
• Identifying Risks Introduced by Risk Control Measures
• Monitoring the Effectiveness of Risk Controls Throughout the Device Lifecycle
• Documentation and Reporting Requirements for Risk Control and Evaluation Activities

Day — 4 Production and Post-Production Risk Management

• Importance of Production and Post-Production Risk Management in Medical Device Safety
• Production and Post-Production Surveillance Requirements Under ISO 14971:2019
• Post-Production Activities Supporting Quality Management Systems (QMS)
• Monitoring, Reviewing, and Updating Risk Management Information
• Conducting Periodic Risk Management Reviews and Continuous Improvement Activities
• Developing and Maintaining a Comprehensive Risk Management File
• Adverse Event Reporting, Investigation, and Corrective Action Processes
• Using Post-Market Data to Identify Emerging Risks and Improve Device Safety
• Integrating Production and Post-Production Feedback into the Risk Management Process

Day — 5 Preparation for Audits

• Understanding Internal and External Audit Requirements for ISO 14971:2019
• Audit Expectations and Compliance Verification Processes
• Preparing for ISO 14971:2019 Audits: Strategies and Best Practices
• Documentation and Evidence Requirements for Risk Management Audits
• Common Audit Findings and Approaches to Address Non-Conformities
• Tools and Techniques for Maintaining Effective Risk Management Systems
• Best Practices for Demonstrating Risk Management Compliance Throughout the Medical Device Lifecycle
• Case Studies: Risk Management Applications in Medical Device Development
• Final Presentation: Developing and Presenting a Medical Device Risk Management Plan

Learning Outcomes

Upon successful completion of this course, participants will be able to:

• Understand the scope, purpose, and requirements of ISO 14971:2019 for medical device risk management
• Explain the risk management process and its application throughout the medical device lifecycle
• Develop and maintain risk management plans in accordance with ISO 14971 requirements
• Define management responsibilities and organisational roles within the risk management framework
• Identify hazards and foreseeable risks associated with medical devices, including intended use, misuse, and abnormal conditions
• Apply risk analysis techniques such as:
  • Preliminary Hazard Analysis (PHA)
  • Fault Tree Analysis (FTA)
  • Failure Modes and Effects Analysis (FMEA)
• Evaluate risk control options and verify the effectiveness of implemented controls
• Assess residual risks and determine overall risk acceptability
• Integrate risk management activities into production and post-production processes
• Monitor, review, and update risk management information using post-market data and feedback
• Implement industry best practices and prepare effectively for ISO 14971 compliance audits

Who Should Attend

This course is designed for professionals involved in medical device quality, safety, regulatory compliance, and risk management, including:

• Quality Assurance and Quality Management Professionals
• Risk Management Specialists and Risk Managers
• Regulatory Affairs Professionals
• Medical Device Design and Product Development Engineers
• Compliance Auditors and Regulatory Consultants
• Manufacturing and Production Quality Personnel
• Validation and Verification Engineers
• Medical Device Project Managers and Team Leaders
• Professionals Responsible for Product Safety and Regulatory Compliance
• Individuals Preparing for Leadership Roles in Medical Device Quality, Risk, and Safety Management