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Hi all!
I have several virtual company medical device startups I'm setting up QMS for, and I'm struggling with what a quality manual looks like for this? They will "own" the 510K filing and technical file, but the product will be made and distributed by contracted 3rd parties. I understand the notion of strong supplier quality systems and solid quality agreements, what I'm trying to figure out is what to do with these production sections of the manual and the company SOPs that basically just say it's all done at the CMO. Do we list our requirements as per the regs then, and point to SQA to manage and monitor? Do we exempt it completely from the manual? Examples of how you've done this that have made regulators happy would be greatly appreciated!
I have several virtual company medical device startups I'm setting up QMS for, and I'm struggling with what a quality manual looks like for this? They will "own" the 510K filing and technical file, but the product will be made and distributed by contracted 3rd parties. I understand the notion of strong supplier quality systems and solid quality agreements, what I'm trying to figure out is what to do with these production sections of the manual and the company SOPs that basically just say it's all done at the CMO. Do we list our requirements as per the regs then, and point to SQA to manage and monitor? Do we exempt it completely from the manual? Examples of how you've done this that have made regulators happy would be greatly appreciated!