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.

Click here to learn more about 510(k) applications and their relation to your existing QMS.