Design control for medical devices - what is it and why you should do it

Описание к видео Design control for medical devices - what is it and why you should do it

This is an excerpt from the course "Introduction to Design Control for Medical Devices" which is available at:

https://medicaldevicehq.com/design-co...

Read more about why you should do design control here:

https://medicaldevicehq.com/design-co...

Chapters:
00:00 Introduction
00:18 About the instructor
00:50 Introduction to design control for medical devices
01:07 Is design control required?
02:48 What is design control?
03:45 21 CFR 820 or Quality system regulation (QSR) in the US
04:07 ISO 13485 standard on quality management systems in the EU
04:41 Design control in US vs EU
05:05 Competent authorities
06:24 Additional help and resources

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