My company (9001/17100 certified) is now in the process of investigating certification in 13485 (Med Device). We are a language services provider, so our connection to medical devices is in the translation/localization of documentation, applications, etc. We have no hand in any manufacturing aspects. With that, I was wondering if anyone here had undergone certification for 13845 as a services provider, rather than a manufacturer?
We are trying to ensure this process is as efficient and effective as possible, so any known resources would be superlative. Thank you all.