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 | 1 min 01 secs |
Learning Objectives | 1 min 31 secs |
Who Should Take This Program? | 1 min 21 secs |
Glossary | 1 min 10 secs |
MDSAP Basics | 1 min 14 secs |
MDSAP Audit Model | 1 min 05 secs |
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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