ISO 14971:2018 Application DFMEA Overview

Course Duration: 2 Days - 8 Hours/day

This two-day seminar addresses the application of the FMEA approach to ISO 14971:2019 Application of Risk Management to Medical Devices, and defines the use of DFMEAs as a process within your organization. It provides an overview of the steps of the FMEA process and how it is managed as a process. This course is intended to be a dynamic, hands-on offering with approximately half the class time spent on breakout exercises.

Learning Objectives

Provide a hands-on approach to the medical devices process and its relationship to program deliverables and status reporting to provide the competencies needed to introduce new products and processes smoothly with known risks minimized

Course Outline

  • Framework for Managing Risk
  • Using DFMEA for Integrated Risk Management
  • – Steps of the FMEA Process
  • – Types of FMEAs
  • – Establishing a Team
  • – Developing an FMEA
  • Risk Evaluation
  • Risk Treatment
  • – Safety Tactics
  • Monitoring and Review
  • Summary

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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