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Short course on Clinical Investigation for Medical Devices and ISO 14155
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This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155" which is available at:
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:
We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.
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
Don't forget to follow Medical Device HQ on LinkedIn:
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:
We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.
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
Don't forget to follow Medical Device HQ on LinkedIn:
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