MDSAP Country Specific Requirements (Australia)

Overview

Learning Objectives

Who Should Take This Program?

Glossary

MDSAP Audit Model

MDSAP and Australia

TGA Definition of MDSAP

Auditing the Management Process

Audit Task 8

Auditing the Device Marketing Authorization and Facility Registration Process

Audit Task 1

Audit Task 2

Audit Task 3

Auditing the Measurement, Analysis and Improvement Process

Audit Task 7

Audit Task 12

Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process

Audit Task 1

Audit Task 2

Auditing the Design and Development Process

Audit Task 1

Audit Task 3

Audit Task 5

Audit Task 7

Audit Task 11

Audit Task 13

Auditing the Production and Service Controls Process

Audit Task 8

Audit Task 9

Auditing the Purchasing Process

Audit Task 5

Course updated to v2.0 on 04/04/2023 to reflect FDA update to MDSAP Audit Approach policy document MDSAP AU P0002.008 including changes to: Audit sequence, management process, measurement analysis and improvement process, medical device adverse events and advisory notices reporting, design and development process and production and service controls