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Course Details

ISO 14971 Medical Devices Risk Management

Course Area

Medical Devices

Course Duration

1 Day

Continuing Education Units

0.8

Course Fee

USD $1200.00

Early Bird Price*

USD $1100.00

There are no upcoming classes scheduled.

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Course Details

This course is designed to provide participants with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts.  Participants will also understand how ISO 14971 applies to ISO 13485.

The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations.

Learning Objectives

  • Identify the links between ISO 13485 (QMS) and ISO 14971 (RM)
  • Explain how risk management relates to the product lifecycle
  • Define risk management terminology
  • Outline the stages of the risk management process
  • Define the key deliverables of the risk management process

Who Should Attend?

  • Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel
  • Decision makers on management system strategy
  • Internal Auditors

Prerequisite 

Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485

This course can be delivered as in-company training, customized for specific organizations and their circumstances


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Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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