This is a short course on design control for medical devices. 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 Design Control for Medical Devices, which is available at:

https://medicaldevicehq.com/design-control

Chapters:
00:00 About the instructor
00:14 Introduction of the short course
00:37 Learning objectives
01:08 What is design control for medical devices?
01:24 Why you need to understand design control requirements
01:50 Why you need to perform design checks for medical devices
03:00 Understand industry-specific language
04:08 What is intended use or intended purpose?
05:30 What are user needs?
05:48 Translation user needs to design input
06:52 Design verification is a legal requirement
07:38 Design validation as a legal requirement
08:34 Competent authorities in the EU and the US
09:15 Notified bodies inspect medical device manufacturers
09:55 Summary of key development terms for medical devices
10:14 The phases of the project management process
16:40 Extra help and resources

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