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Documents library

Procedure

MDSAP AS P0020.002

Special On-Site Assessment Procedure

12 November 2019

Procedure

MDSAP AS P0034

Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations

26 September 2019

Flowchart

MDSAP AS F0015.1

AO Nonconformity Flowchart

28 November 2017

Report

2017

MDSAP Final Pilot Report June 2017

29 June 2017

Procedure

MDSAP P0007

Proof of Concept for MDSAP Pilot

24 February 2017

Policy

MDSAP AU F0008.2

Audit Duration Calculation Form (Audit Model 2017)

24 January 2017

Flowchart

MDSAP AS F0017.1

Technical Review and Recognition Decision Flowchart

26 September 2016

Form

MDSAP AS F0010.6

AO Application Matrix

15 August 2016

Guide

IMDRF/MDSAP WG/N3 FINAL

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

24 March 2016

Policy

IMDRF/MDSAP WG/N3 FINAL:2016 (Edition 2)

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

24 March 2016