Understanding ISO 14971:2019 Risk Management to Medical Devices

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

Course Duration: 2 Days - 8 Hours/day

This two-day course 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.

Note: For ISO 14971 Advanced Risk Management Training with DFMEA and PFMEA, Please Click Here.

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.

Pre-Requisite

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.

Upcoming Training

Provide this course Onsite
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For Implementation Support

ISO 14971:2019 Understanding Application of Risk Management to Medical Devices Training Course Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.