How to do a medical device design review

Hi Peter and thanks for your video on Design Reviews.
I would like to know whether the technical reviews should be part of the Quality Management System and the Design History FIle. Technical Design reviews are used to show technical aspect of the design and they are prerequisite for the design reviews. But do we need to include them in the DHF ? If not how can we show that the technical aspects have been evaluated solved?

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Can you explain in more details what is the role of the indepedent reviewer during the design review ? We don't have this requirement in Europe. Thank you.

What should be the content to be covered in design control for prefilled syringes with passive needle guard?
Is it necessary to have design review for this device?

I think Design Reviews are value adding in a sense that they act as a central node (or convergence) of the documentation and design decisions – afterwards, a sort of divergence takes over until the next Design Review.



Having held many Design Reviews the past years, I seem to struggle with conveying the value of the meeting to many of my stakeholders. I use terms the same as you: “pause”, “reflect”, etc., however, when talking to a specialist, they are sometimes used to / expects to run through each requirement in a detailed manner (much like a Technical Review), and if not: “then what is the value other than sitting and talking at a very high level?”

That being said, I experience that most (not all) stakeholders see the value after the Design Review has been held, and they willingly participate in subsequent reviews.


Thank you for a good and concise presentation – I am happy to see, that I use the same approach as you :)

I have an assignment on medical device design control
I know all the definitions but dont know how to apply on a specific product
Like ventilator
Can u plz help me
Thanks

Really good to have.