This is an excerpt from the course "Introduction to Design Control for Medical Devices" which is available at:
[ Ссылка ]
Starting October 2023, the template mentioned in the video is no longer available for free on Medical Device HQ. However, a more comprehensive paid version is now accessible via this link:
[ Ссылка ]
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.
Read more about medical device design reviews in our article here:
[ Ссылка ]
Chapters:
00:00 Introduction
00:24 About the instructor
00:45 What is a medical device design review?
01:21 Why you should perform design reviews for medical devices
01:41 Design review in QSR and design and development review in ISO 13485
02:09 The difference between a design review and steering group meetings
02:42 When you should perform design reviews
03:54 Who should be present during a design review?
04:50 How to determine who is classified as an independent person
05:41 Addressing nonconformities
06:27 Use checklists for the stages of development
07:24 Maintain design review records
08:41 Additional help and resources
09:11 A common pitfall - insufficient follow up on action items
10:28 Schedule a follow-up meeting to ensure action items have been addressed
