MDSAP

MDSAP Country Specific Requirements (USA)

In previous courses, we focused on providing a high-level overview of each of the process chapters of the Medical Device Single Audit Program (MDSAP). Consequently, the country-specific MDSAP requirements are reviewed separately from these general MDSAP courses. In this course, we will focus on providing a detailed discussion of the United States Food and Drug Administration’s country-specific requirements for the process chapters of MDSAP, as they were not covered in detail in the general MDSAP courses.

Book a Demo

CEU Credits: 0.1

Course Code: ELM-143

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

MDSAP and the USA

Benefits of MDSAP to the USA

USA Regulatory Authorities and MDSAP Exclusions

Chapter 1 – Process: Management

Auditing the Management Process

Audit Task 8

Chapter 2 – Process: Device Marketing Authorization and Facility Registration

Auditing the Device Marketing Authorization and Facility Registration Process

Audit Task 1

Audit Task 2

Audit Task 3

Chapter 3 – Process: Measurement, Analysis and Improvement

Auditing the Measurement, Analysis and Improvement Process

Audit Task 1

Audit Task 12

Audit Task 12: US FDA-Specific Requirements

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

Chapter 5 – Process: Design and Development

Auditing the Design and Development Process

Audit Task 4

Audit Task 5

Audit Task 8

Audit Task 13

Audit Tasks 14

Chapter 6 – Process: Production and Service Controls

Auditing the Production and Service Controls Process

Audit Task 1

Audit Task 7

Audit Task 16

Audit Task 17

Audit Task 18

Audit Task 21

Audit Task 25

Audit Task 27

Conclusion

Final Assessment

Certification

Revision History

Course updated to v2.0 on 4/4/2023 to reflect changes in MDSAP regulations. Added player functionality, policy slide, and version history slide. Added information about CEU's and IACET accreditation

Version 2.0