Short course on Clinical Investigation for Medical Devices and ISO 14155
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: https://medicaldevicehq.com/templates/ 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: / medicaldevicehq
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