MDSAP

Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4

Upon completion of this course, you will have a comprehensive understanding of the general MDSAP requirements that affect all five MDSAP countries, including the following content from the Audit Model, MDSAP Basics, MDSAP Audit Model, Chapter 1: Process: Management, Chapter 2: Process: Audit Tasks and Links, Chapter 3: Process: Measurement, Analysis and Improvement and Chapter 4: Process: Medical Device Adverse Events and Advisory Notices Reporting.

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CEU Credits: 0.1

Course Code: ELM-138

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V2.0

Effective Date: 04/04/2023

Curriculum for this course

Introduction

Overview

Learning Objectives

Who Should Take This Program?

Glossary

MDSAP Basics

MDSAP Audit Model

Chapter 1 – Process: Management

Auditing the Management Process

Audit Task 1

Audit Tasks 2 and 3

Audit Tasks 4 and 5

Audit Task 6

Audit Task 7

Audit Task 8

Audit Tasks 9, 10, and 11

Chapter 2 – Process: Device Marketing Authorization and Facility Registration

Auditing the Device Marketing Authorization and Facility Registration Process

Audit Tasks 1 and 2

Audit Task 3

Chapter 3 – Process: Measurement, Analysis and Improvement

Auditing the Measurement, Analysis and Improvement Process

Audit Task 1

Audit Task 2

Audit Tasks 3, 4, and 5

Audit Tasks 6 and 7

Audit Tasks 8, 9, and 10

Audit Tasks 11, 12, and 13

Audit Tasks 14, 15, and 16

Chapter 4 – Process: Medical Device Adverse Events and Advisory Notices Reporting

Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process

Audit Task 1

Audit Task 2

Conclusion

Final Assessment

Certification

Revision History

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

Version 2.0