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