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Documents library

Report

MDSAP AU F0019.1

Medical Device Regulatory Audit Report

2 January 2025

Template

MDSAP AS F0017.4

Letter of Recognition Template

1 November 2024

Form

MDSAP AS F0015.2

AO Nonconformity Report

30 August 2024

Procedure

MDSAP AU P0026

Certification Document Requirements

12 August 2024

Policy

MDSAP AU P0002

Audit Approach

6 August 2024

Flowchart

MDSAP AS F0014.1

Special Documentary Assessment Flowchart

4 April 2024

Report

MDSAP AS F0014.2

Special Documentary Assessment Report

4 April 2024

Procedure

MDSAP AU P0029

Communication by AOs with RA on Organizations Participating in MDSAP

7 March 2024

Guide

MDSAP AU G0019.3

Medical Device Regulatory Audit Report Form Guidelines

21 February 2024

Guide

MDSAP AU G0019.4

Guidelines NC Grading Exchange Form

21 February 2024