Fda Medical Device Single Audit Program

Operating a single audit program that provides confidence in program outcomes.

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. To enable the appropriate regulatory oversight of medical device manufacturers quality management systems while. 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. Fda tga anvisa hpfb cooperation in the medical device single audit program mdsap português français.