ISO14971

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 full Introduction to Risk Management and ISO 14971 online course can be found here: medicaldevicehq.com/iso14971

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

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