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Understanding ISO 14971:2019 Application of Risk Management to Medical Devices

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Seminar Content

This two-day seminar addresses all of the elements of the ISO 14971:2019 Application of Risk Management to Medical Devices, and defines it as a process within your organization. It provides an overview of the six steps of the Risk Management process and how it is managed as a process. An overview and examples of the Risk Analysis Tools listed in ISO/TR 24971:2019 is also included.

Who Should Attend

Those who have direct responsibility for introducing new medical devices and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical devices development and improvement.

Recommended Training and/or Experience

No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Seminar Goals

  • Explore the specifics of ISO 14971:2019, the Application of risk management to medical devices.
  • Provide a hands-on approach to the medical devices process and its relationship to program deliverables and status reporting.
  • Provide the competencies needed to introduce new products and processes smoothly with known risks minimized.

Seminar Agenda

  • Chapter 1: What is Risk?
    • Breakout Exercise 1: Defining Risk for Medical Devices
  • Chapter 2: Managing Risk
    • Fundamental Risk Concepts
    • Risk Management Process
    • Management Responsibilities
    • Competence of Personnel
    • Breakout Exercise 2: Identifying Management Responsibility and Competency of Personnel
    • Risk Management Plan
    • Risk Management File
    • Breakout Exercise 3: Composing a Risk Management Plan
  • Chapter 3: Risk Assessment and Analysis
    • Risk Assessment
    • Risk Analysis Process
    • Intended Use and Reasonably Foreseeable Misuse
    • Identification of Characteristics Related to Safety
    • Identification of Hazards and Hazardous Situations
    • Risk Identification Methods
    • Risk Estimation
    • Breakout Exercise 4: Identifying Risk Elements
  • Chapter 4: Risk Analysis Tools
    • Preliminary Hazard Analysis
    • Fault Tree Analysis
    • Event Tree Analysis
    • Failure Mode and Effects Analysis (FMEA)
    • Hazard and Operability Study (HAZOP)
    • Hazard Analysis and Critical Control Point (HACCP)
    • Breakout Exercise 5: Using Risk Estimation Techniques
  • Chapter 5: Risk Evaluation
    • Risk Evaluation
    • Risk Acceptability
    • Breakout Exercise 6: Identifying Higher Level Risk Elements
  • Chapter 6: Risk Treatment and Control
    • Risk Control Option Analysis
    • Implementation of Risk Control Measures
    • Residual Risk Evaluation
    • Benefit-Risk Analysis
    • Risks Arising from Risk Control Measures
    • Completeness of Risk Control
    • Breakout Exercise 7: Conducting Risk Control Review
  • Chapter 7: Risk Management Monitoring and Reviewing
    • Evaluation of Overall Residual Risk
    • Risk Management Review
    • Production and Post-Production Activities
    • Breakout Exercise 8: Conducting Risk Management Review and Overall Residual Risk

Understanding ISO 14971:2019 Application of Risk Management to Medical Devices

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