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

Description:

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.

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 1 min 05 sec
Audit Task 1 1 min 10 secs
Audit Tasks 2 and 3 1 min 08 secs
Audit Tasks 4 and 5 1 min 17 secs
Audit Task 6 1 min 48 secs
Audit Task 7 1 min 02 secs
Audit Task 8 1 min 10 secs
Audit Tasks 9, 10, and 11 1 min 10 sec
Chapter 2 – Process: Device Marketing Authorization and Facility Registration
Auditing the Device Marketing Authorization and Facility Registration Process 1 min 12 secs
Audit Tasks 1 and 2 1 mins 29 secs
Audit Task 3 1 min 55 secs
Chapter 3 – Process: Measurement, Analysis and Improvement
Auditing the Measurement, Analysis and Improvement Process 1 min 01 secs
Audit Task 1 1 min 13 secs
Audit Task 2 1 min 33 secs
Audit Tasks 3, 4, and 5 1 min 06 secs
Audit Tasks 6 and 7 1 min 19 secs
Audit Tasks 8, 9, and 10 1 min 27 secs
Audit Tasks 11, 12, and 13 1 min 04 secs
Audit Tasks 14, 15, and 16 1 min 03 secs
Chapter 4 – Process: Medical Device Adverse Events and Advisory Notices Reporting
Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process 1 min 10 secs
Audit Task 1 1 min 01 secs
Audit Task 2 1 min 25 secs
Conclusion
Final Assessment
Certification
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