ISO 14971:2019 Application of Risk Management to Medical Devices Including DFMEA and PFMEA

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Course Duration: 5 Days - 8 Hours/day

This five-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.

This seminar will also provide a hands-on experience with the linkages between various aspects of the Advanced Product Quality Planning (APQP) process. Specifically, the development and linkage of Block Diagrams, Interface Matrix, System and Design FMEAs and Design Verification (Test) Plans (DVPs), as well as planning and developing the manufacturing system and processes in preparation for a product launch as well as the management of continual improvement.

This class includes breakout exercise sessions using an example of a Medical Device sub-assembly project and product launch.

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.

·      Provide a hands-on approach to S/DFMEAs and their relationship to program deliverables and status reporting

·      Provide the competencies needed to introduce new products and processes smoothly

·      Gain knowledge and understanding in:

o   Block Diagrams and Interface Matrix

o   Linkages between Block Diagrams, SFMEAs, DFMEAs, DVP and other design tools

o   Linkages between PFMEAs and S/DFMEAs

o   Using FMEA as an analytical process

o   S/DFMEAs and DVPs

·      Gain knowledge and understanding in:

o   Process Flows

o   Linkages between Process Flows, PFMEAs, Control Plans and Work Instructions

o   Linkages between PFMEAs and S/DFMEAs

o   Using FMEA as an analytical process

o   Characteristics Matrix

o   Process FMEAs and Control Plans

·      Chapter 1: What is Risk?

o   Breakout Exercise 1: Defining Risk for Medical Devices

·      Chapter 2: Managing Risk

o   Fundamental Risk Concepts

o   Risk Management Process

o   Management Responsibilities

o   Competence of Personnel

o   Breakout Exercise 2: Identifying Management Responsibility and Competency of Personnel

o   Risk Management Plan

o   Risk Management File

o   Breakout Exercise 3: Composing a Risk Management Plan

·      Chapter 3: Risk Assessment and Analysis

o   Risk Assessment

o   Risk Analysis Process

o   Intended Use and Reasonably Foreseeable Misuse

o   Identification of Characteristics Related to Safety

o   Identification of Hazards and Hazardous Situations

o   Risk Identification Methods

o   Risk Estimation

o   Breakout Exercise 4: Identifying Risk Elements

·      Chapter 4: Risk Analysis Tools

o   Preliminary Hazard Analysis

o   Fault Tree Analysis

o   Event Tree Analysis

o   Failure Mode and Effects Analysis (FMEA)

o   Hazard and Operability Study (HAZOP)

o   Hazard Analysis and Critical Control Point (HACCP)

o   Breakout Exercise 5: Using Risk Estimation Techniques

·      Chapter 5: Risk Evaluation

o   Risk Evaluation

o   Risk Acceptability

o   Breakout Exercise 6: Identifying Higher Level Risk Elements

·      Chapter 6: Risk Treatment and Control

o   Risk Control Option Analysis

o   Implementation of Risk Control Measures

o   Residual Risk Evaluation

o   Benefit-Risk Analysis

o   Risks Arising from Risk Control Measures

o   Completeness of Risk Control

o   Breakout Exercise 7: Conducting Risk Control Review

·      Chapter 7: Risk Management Monitoring and Reviewing

o   Evaluation of Overall Residual Risk

o   Risk Management Review

o   Production and Post-Production Activities

o   Breakout Exercise 8: Conducting Risk Management Review and Overall Residual Risk

·      Chapter 8: Introduction to Failure Mode and Effects Analysis (FMEA)

·      Chapter 9: Developing an FMEA

·      Chapter 10: Design FMEA Prerequisites

o   Breakout Exercise 9: Customers and Functional Requirements

o   Breakout Exercise 10: Boundary Diagram

·      Chapter 11: Developing the Design FMEA

o   Breakout Exercise 11: Starting the DFMEA Form

o   Breakout Exercise 12: Failure Modes

o   Breakout Exercise13: Design Causes

o   Breakout Exercise 14: Design Controls

o   Breakout Exercise 15: Effects, Severity and Action Plans

·      Chapter 12: Characteristics Flowdown

·      Chapter 13: Test Planning and Reporting

·      Chapter 14: Process FMEA Prerequisites

o   Breakout Exercise 16: Process Flow Diagram

·      Chapter 15: Developing the Process FMEA

o   Breakout Exercise 17: Starting the PFMEA Form

o   Breakout Exercise 18: Potential Causes

o   Breakout Exercise 19: Process Controls

o   Breakout Exercise 20: Effects, Severity and Action Plans

·      Chapter 16: Control Plan

o   Breakout Exercise 21: Creating a Control Plan

·      Chapter 17: Work Instruction Development


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. 

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

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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