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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?
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?