Design stage overview (Product specification)

#1
Hi Medtech Community,
In process of remediation of the technical file from MDD to MDR, trying to update appropriate section and stuck on design process description. In my case there is medical device of safety class I (Sterile) Covers for surgical equipment. Legal manufacturer: Company A who owns specifications (well-know and long time ago established devices) on MD and Contract manufacturer: Company B, who produced devices under our specifications. There are no design and development activities, so no appropriate procedures or documents available. But I do understand that still must be indicated information how specification created, based on what and how its validated to meet customers expectations.
Is it true or I am heading into incorrect way?
 
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#3
Hi,
if you do not have a "design file", you need to create it... MDD tech file can be used as one of the inputs.
'Hello, thank you for your reply, but...
Unfortunately, Design section of the MDD Tech file contained general information like: device is in production phase, briefly information on suppliers, on QC procedures, sterilization, etc. Literally 1 page and that's it.
For my opinion specification design and development should be considered as design stage with proper process and information on control adn changes, verification that specification meet customer needs, etc.
 
Last edited:

Billy Milly

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#4
You are heading the right way. Gather all relevant inputs (existing file can be one of them), process them and provide a suitable output for every input by covering all the design phases in between. Take ISO 13485, 7.3 for guidance.
 
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