Medical Device Single Audit Program (MDSAP) – TGA, MDR, EU and more…………………………………….
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 recognized auditing organization, to satisfy the needs of multiple regulatory jurisdictions.
How can CMS support you?
If you like to participate in the program please contact me for further information.
George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer |
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