Short course on Clinical Investigation for Medical Devices and ISO 14155
Автор: Medical Device HQ
Загружено: 2022-05-11
Просмотров: 10954
This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155" which is available at:
https://medicaldevicehq.com/introduct...
Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link:
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Chapters:
00:00 Introduction
00:31 About the instructor
01:15 Learning goals
01:57 About the standard
02:35 What is clinical investigation?
04:52 Which medical devices need a clinical investigation?
06:32 Good Clinical Practice - GCP
07:41 ICH
08:48 ISO 14155
10:21 Stakeholders
13:10 Summary of GCP principles
15:25 Drugs vs. devices
16:30 Clinical investigation milestones
17:23 Budget
18:10 Additional resources
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