Article on MDSAP Documents added to the Ombu Library

The Ombu Library, in the MDSAP aisle, has an article that identifies three documents that are important to medical device manufactures who anticipate an audit under the Medical Device Single Audit Program, MDSAP. It identifies the FDA website with its links to the MDSAP documents and briefly describes the Audit Document and the Companion Document. In addition, it the GHTF document that describes the nonconformity grading system.