MDSAP Country Specific Requirements (Brazil)

Overview

Learning Objectives

Who Should Take This Program?

Glossary

MDSAP Basics

MDSAP Audit Model

MDSAP and Brazil

Exclusions and ANVISA

Auditing the Management Process

Audit Task 6

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 1

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 8

Audit Task 13

Audit Task 16

Auditing the Production and Service Controls Process

Audit Task 4

Audit Task 5

Audit Task 6

Audit Task 7

Audit Task 16

Audit Task 17

Audit Task 21

Audit Task 25

Audit Task 27

Auditing the Purchasing Process

Audit Task 8

Audit Task 10

Course updated to v2.0 on 4/4/2023 to update content related to regulations. Additional updates were made to the plCourse 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