Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
Lisa- Welcome to the Cove!! I see you are in the Rochester Area as well.
My take on if you are Design Responsible is? if the customer is paying you to design a product, product design cannot be excluded.
Your other question about how will the FDA accept you using a sub-contractor for design. Are you asking if they will allow it??
Good day. For additional clarification, the specification developer is the person or company who owns the class I, II, III product [510(k) or PMA depending upon the FDA classification] & has name on labeling (approves product specifications, labeling &/or packaging). In many cases, the spec developer does not have the resources, technical know-how, and/or equipment/ facilities to design and/or manufacture the product. Thus, the company finds contract design houses and/or contract manufacturers (if they also do design controls). These 21 CFR 820 operations are handled by the contract company(ies), but under purchasing controls, the spec developer is ultimately responsible for the design and/u=or manufacture of the medical device. (Note: Certain class I, but all class II and all class III FDA medical devices have to undergo design controls).
FYI- I worked for the FDA as an international level II certified medical device investigator for over 21 years...
I hope this helps.