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
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-138 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Aligned directly with the MDSAP regs, this is a great course to get anyone up to speed fast with the expectations from inspectors.
Excellent layout, clear and concise. This course breaks down the requirements into manageable chunks.
Related courses:
Medical Device Single Audit Program (MDSAP) – Part 1
Medical Device Single Audit Program (MDSAP) – Part 2
Medical Device Single Audit Program (MDSAP) – Part 3
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
ISO 13485:2016 Product Realization (Chapter 7 – Part A)
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)
ISO 13485:2016 – Product Realization (Chapter 7 – Part B)
Talk to us
Find out how we can help you bring your life science training to the next level.