lisa1666 said:
I have a question regarding design. My company does not design/engineer, we are using a contract engineering firm for this. We purchased the rights to a device and needed some modifications, which included complete processor change, source code and the like. My company is outsourcing most operations. We will be performing the final integration/inspection though; does this make us responsible for the design functions? Do I need to include design in my ISO 13485 manual. I have taken an exclusion to it so far, though I have not been certified or even audited yet. I'm still in the process of writing it. Another question is will the FDA accept us using a 3rd party engineering firm for design? I'm a bit stuck here, any help you could offer will be greatly appreciated!
FWIW my take on it is that 13485 allows exclusion of design and development controls
only if regulatory requirements permit exclusions (ref: 1.2 Application). I don't see where the FDA QSR permits this (Ref: 21cfr820.30, Design controls). So to take an exclusion, the FDA regulations would have to allow it.
How do you control your sub-contactor? What controls does your sub-contractor have? Is your sub-contractor experienced with med. dev's and the neccessary controls? You can control the design that way. I think then the FDA would accept that, but your sub-contractor would be subject to an FDA Inspection.
To see what's required read through the FDA regulation I referred to above, if you haven't already. I'll bet you're doing some of it and your sub-contractor is doing the rest or should be.