Fda Medical Device Single Audit Program

The medical device single audit program allows an mdsap recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant.
Fda medical device single audit program. The overall objective of the medical device single audit program is to develop manage and oversee a single audit program that will allow a single regulatory audit of a medical device manufacturer conducted by an mdsap recognized auditing organization to satisfy the needs of multiple regulatory jurisdictions. The medical device single audit program mdsap is intended to allow competent auditors from mdsap recognized auditing organizations aos to conduct a single audit of a medical device. Operating a single audit program that provides confidence in program outcomes. Fda tga anvisa hpfb cooperation in the medical device single audit program mdsap português français.