K
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
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