Medical Device Single Audit Program (MDSAP) – TGA Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits. What is the MDSAP? The objective of the MDSAP 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 … Continue reading MDSAP – Medical Device Single Audit Program