I agree with @tme3 that the ambiguity of GMP’s could actually be beneficial to a startup because it allows for a little more flexibility to create their own quality system and since each company is different with different products there would inevitably be different manufacturing processes. I also agree how others have stated that for a start-up it with no pre-existing GMPs, it would be difficult to know where to begin on how to build their own system in accordance with FDA/ISO requirements. However there are companies and consultants that start-ups could use to obtain guidance on where to begin and can develop nd implement a streamlined, cost-efficient quality plans. One example of a company that does exactly this is called Compliance Gurus. Overall, I don’t this ambiguity makes sets them up for initial failure, but rather the ambiguity could be seen a positive attribute that allows for more flexibility into creating a quality system that is right for that company. I think it could be more difficult process for start-ups that don’t have pre-existing GMPs, but they could receive guidance from other experts/consulting companies that could help them get started.

compliancegurus/medical_devices