Understanding ISO 14971:2019 Risk Management

Course Duration: 2 Days - 8 Hours/day

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.

Learning Objectives

  • 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.

Course Outline

  • 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

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.

Course Materials

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

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.


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.

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