Re: Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements
At some point I would think you would want to have a formal review of the previous company's DHF and document your approval of its completeness and suitability for transfer within your company. In that case, you may be able to set up a review document with your company's specific format, definitions, references, etc. and then append the previous DHF as an attachment and keep that within your quality system documentation. Any "gaps" or risks found during the review would then be addressed with actions, such as the process validation you've noted. And it may include some need to transcribe documents from the previous owner if you find gaps or if you feel there is a risk inherent in using the previous documents.
Then complete the necessary actions to fill the gaps and mitigate the risks...of course if you reach a conclusion that some re-design is needed, that may require a new 510K submission! But you should then have a complete and effective DHF transferred to your manufacturing unit!