This is an online short course on Risk Management for Medical Devices and ISO 14971:2019. It also includes a comparison between ISO 14971 risk management and FMEA.

The course is great for onboarding employees, and the participant will receive a course certificate upon completion.

The full Introduction to Risk Management and ISO 14971 online course can be found here: [ Ссылка ]

Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link:

[ Ссылка ]

We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.

Chapters
00:00 About the instructor
00:24 Introduction to this short course
00:41 Learning goals of this short course
01:14 Implementing an ISO 14971 risk management process
01:31 Creating a safe medical device
02:01 The ISO 14971 definition of safety
02:53 What is risk management for medical devices?
03:23 An overview of the risk management process
04:17 Risk management is a requirement in the US and the EU
05:03 The risk management process from start to end
07:18 The ISO 14971 definition of risk
07:31 Estimating the probability of occurrence of harm (Po)
08:36 Risk control options analysis
08:58 Risk control measures
09:21 Verification of effectiveness
10:03 Implementation of risk controls
10:28 Estimating the residual risk
11:16 Risk management review and the risk management file
12:39 Production and post-production activities
13:54 An overview of the FMEA
14:30 ISO 14971 risk management vs. IEC 60812 FMEA
16:16 Additional help and resources

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