This is an excerpt from the course "Introduction to Risk Management for Medical Devices and ISO 14971:2019" which is available at:
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Read more about how to work with medical device risk management here:
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Chapters:
00:00 Introduction
00:25 What this video will cover
01:17 What does FMEA stand for?
02:00 The advantages of using standard terms and concepts
02:54 What is FMEA according to the standard?
04:54 FMEA vs ISO 14971 risk management
09:02 Should you use FMEA?
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