IMDRF/MDSAP WG/N3 FINAL: 2016 (Edition 2) Requirement for Medical Device Audition Organizations for Regulatory Authority Recognition

The linked document is one document in a collection of documents produced by the International Medical Device Regulators Forum (IMDRF) intended to implement the concept of a Medical Device Single Audit Program (MDSAP).

This document defines the requirements for medical device Auditing Organizations performing regulatory audits and other related functions.