This is a short course in medical device design control. The goal is to give you a basic understanding of what design control is.

The short course is also a preview of the full online course: Introduction to Medical Device Design Control, available at:

https://medicaldevicehq.com/design-control

Chapters:
00:00 About the instructor
00:14 Introduction to the short course
00:37 Learning objectives
01:08 What is medical device design control?
01:24 Why you need to understand design control requirements
01:50 Why you should perform design checks for medical devices
03:00 Understanding industry-specific language
04:08 What is intended use or intended purpose?
05:30 What are the user needs?
05:48 Translate user needs to design inputs
06:52 Design verification is a regulatory requirement
07:38 Validation of the design according to regulatory requirements
08:34 EU and US Competent Authorities
09:15 Notified bodies audit medical device manufacturers
09:55 Summary of key terms in medical device development
10:14 The phases of the project management process
4:40 p.m. Additional help and resources

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