Industry has long dreamt of a single-audit mechanism to satisfy the requirements of the various regulatory jurisdictions, and a session on the last day of the Advanced Medical Technology Association (AdvaMed; Washington) 2013 meeting demonstrated that goal is close to being realized. Kim Trautman, FDA's liaison to the International Medical Device Regulators Forum, said auditing entities who wish to participate in the Medical Device Single Audit Program (MDSAP) can start enrolling, but she also urged device makers to take part in the pilot, which could help ward off a proliferation of additional regulatory schemes across the globe. Read More
