Technology and testing transfer to a new brand - Technical files

[medprodev]

I am working on a technical file for a CE submission (ISO 13485). My primary employer, Company P, has launched a joint venture (40% ownership) and we are manufacturing the exact same product using identical processes at a new facility in another country under a different brand name, Company S. Company P has a current CE mark on the product. When I submit the technical file I will be supply the biocompatibility testing, process and cleaning validations and test results, etc. that I used at Company P and asserting we do not need to redo most of the testing given that all of the processes, materials, and manufacturing equipment are identical.

I would like to write a short cover page to my technical file or sections of my technical file that inform the reviewer why they will be seeing Company P on the test results. Is there a template or formal procedure I can follow or reference to create this cover page?

 

[Ronen E]

Hello medprodev and welcome to the Cove

asserting we do not need to redo most of the testing given that all of the processes, materials, and manufacturing equipment are identical.

If I was to review such a file I would seriously doubt that all those are actually identical, at least unless your home country and the new site’s one are geographically and culturally close and knowledgeable and experienced people from P were very closely involved in all aspects of S’s line set-up. A blanket statement such as the above is likely to produce resistance; I would recommend that you go to some effort to actually provide details and convince that all those elements are indeed identical.

I would like to write a short cover page to my technical file or sections of my technical file that inform the reviewer why they will be seeing Company P on the test results. Is there a template or formal procedure I can follow or reference to create this cover page?

I do not know of such standard template/procedure, and I also don’t think you need one. Just prepare a factual statement on the company’s letterhead and include at the beginning.

Cheers,
Ronen.