Design Control for Medical Devices - Online introductory course
There is an updated version of this video here: • Short course on design control for medical... The newer version of the video uses terminology that is aligned with the Quality Management System Regulation (QMSR) that became effective on the 2nd of February, 2026. 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: 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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Design control for medical devices - what is it and why you should do it
Determining User Needs for Your Medical Device
Medical Device Regulations / FDA Approval
