Risk Management and Analysis in Medical Device Manufacturing : Manufacturing Process Development using PFMEA for Medical Devices

Course Duration: 2 Days - 8 Hours/day

This two-day seminar addresses the application of the FMEA approach to ISO 14971: Application of Risk Management to Medical Devices, and defines the use of PFMEAs 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
  • Manufacturing Processes and Risk Control (PFMEA)
  • Process Requirements
  • Process Flow Diagram
  • Process Failure Modes
  • Potential Causes
  • Process Controls
  • Risk Evaluation
  • Risk Treatment
  • 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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