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Integrating acquired existing product into Quality Management System Records

K

Kuang

#1
Hi all

First time posting here. Our company is currently in the R&D stage of making a design change to an existing product that we acquired externally. The product is a medical device that performs laser eye surgery, and we are looking to receive a CE mark for it. What do we need to do to satisfy the requirements (ISO/CE certification) to implement this product into our records? I was told to implement the product like a new product and demonstrate Planning + Input + Output + Design Review + Verification + Validation. However, our procedure and existing documents for new product design are not tailored for this and seem far too complex and unnecessary. We have the technical file for this product. Any insight would be greatly appreciated.

Respectfully,

Kuang
 
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yodon

Staff member
Super Moderator
#3
Hmm... Don't know about the Planning part but the other stuff is pretty standard for design changes (and enabling subsequent release). If you're making a design change, you may impact requirements (inputs), will definitely affect (design) outputs, will show review when you close out the design change, will need to prove the requirements are still met (verification), and will need to show that user needs are still met (validation).

I can see how doing a Plan would be helpful to show how you've incorporated the artifacts, how you will assess the impacts, and how you will change, test, and release the update. This would also help transition from approvals by previous company into approvals by your company.

Out of curiosity, what do you feel is too complex and / or unnecessary?
 
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