Documents library

MDSAP Final Pilot Report June 2017

29 June 2017

Proof of Concept for MDSAP Pilot

24 February 2017

Audit Duration Calculation Form (Audit Model 2017)

24 January 2017

Technical Review and Recognition Decision Flowchart

26 September 2016

AO Application Matrix

15 August 2016

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

24 March 2016

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

24 March 2016

Medical Device Regulatory Audit Reports

2 October 2015

MDSAP Mid-Pilot Report, August 2015

1 August 2015

MDSAP Functional Statement

24 July 2015