Скачать с ютуб Design Control for Medical Devices - Online introductory course в хорошем качестве

Design Control for Medical Devices - Online introductory course

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