Hello Anonymous,
It is hard to respond without knowing more.
What standard was initially used to create the device?
How was the device initially validated? Cadaver, report from Engineer?
Why is the change being made?
Has a risk analysis been performed to assess the risks associated with the change?
What do you mean by "submit the change code?
Even without these details I don't see how making the change and releasing it to the market for surgeons to validate could be acceptable. Or are you thinking of performing a study with the proposed modification as an investigational device?
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Jean Bigoney PhD, RAC, CQE
Senior Regulatory Affairs Specialist
Cary NC
United States
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Original Message:
Sent: 09-Nov-2021 09:31
From: Anonymous Member
Subject: R&D parts validation activities
This message was posted by a user wishing to remain anonymous
Dear Team,
Please I need your experience feedback.
As personalized cutting guide manufacturer using software, I want to know how we should to proceed to validate a change in our device.
For major change in the design should we:
- carry out cadaver lab for V&V activities ( too expensive) or
- a rational report from engineer ( is it sufficient) or
-create a R&D part witch will be use by surgeon for validation after using ( is it compliante)
- Do we need to submit the change code in the software?
please could you tell me what is the best practice generally used in the medical device area?
Thank you in advance.
Rgds,