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Design Control for Medical Devices - Online introductory course
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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:
Chapters:
00:00 About the instructor
00:14 Introduction to the short course
00:37 Learning goals
01:08 What is design control for medical devices?
01:24 Why you need to understand design control requirements
01:50 Why you should do design controls for medical devices
03:00 Understand the industry-specific language
04:08 What is intended use or intended purpose?
05:30 What are user needs?
05:48 Translate user needs to design input
06:52 Design verification is a regulatory requirement
07:38 Design validation s a regulatory requirement
08:34 Competent authorities in the EU and the US
09:15 Notified bodies audit medical device manufacturers
09:55 Summary of key medical device development terms
10:14 The project management process phases
16:40 Additional help and resources
The short course is also a preview of the full online course: Introduction to Design Control for Medical Devices which is available at:
Chapters:
00:00 About the instructor
00:14 Introduction to the short course
00:37 Learning goals
01:08 What is design control for medical devices?
01:24 Why you need to understand design control requirements
01:50 Why you should do design controls for medical devices
03:00 Understand the industry-specific language
04:08 What is intended use or intended purpose?
05:30 What are user needs?
05:48 Translate user needs to design input
06:52 Design verification is a regulatory requirement
07:38 Design validation s a regulatory requirement
08:34 Competent authorities in the EU and the US
09:15 Notified bodies audit medical device manufacturers
09:55 Summary of key medical device development terms
10:14 The project management process phases
16:40 Additional help and resources
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