How Important are Medical Device Consultants to Quality Management System Reviews and 510(k) Submissions?
Pharma consultants: Already familiar with the Quality Management System (QMS) and the benefits it has in regards to the manufacture of drugs and devices? Do you know how important it is to a medical device 510(k) application?
It is true that some of the minimally suggested 21 sections of the 510(k) can be pulled from your QMS, but most are stand-alone forms and other requirements.
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