Medical Device Single Audit Program (MDSAP) – Part 3
Description:
This course will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the Medical Device company that is considering joining or in the process of joining the program. In addition, an overview of the MDSAP program will be provided, as well as links to more in-depth information on certain topics.
Curriculum for this course:
Introduction
Overview | 45 secs |
Learning Objectives | 1 min |
Who Should Take this Course? | 30 secs |
Terms Explained | 1 min 15 secs |
Course Modules | 35 secs |
Module 5: MDSAP Roles and Responsibilities During the Audit
Audit Tasks: Audit Model Used by Auditor | 1 min 10 secs |
When Are Suppliers Involved in MDSAP? | 1 min 02 secs |
Audit Organizations (AOs) and the Audit | 58 secs |
Auditing Organization: Evaluation and Review | 53 secs |
Auditing Organization Assessments: Regulatory Assessment | 1 min 12 secs |
Regulatory Authority Assessor: Enforcement | 1 min 20 secs |
Appeals to the Regulatory Authorities | 1 min 02 secs |
Auditing Authority Complaints | 1 min 11 secs |
Auditing Organizations: Accreditation | 1 min 09 secs |
Who can become an MDSAP Auditor? | 1 min 14 secs |
Cost and Training for MDSAP Audit Training | 1 min 17 secs |
Roles: Regulatory | 1 min 29 secs |
Roles: Consultancy Organizations | 1 min 02 secs |
Collaboration with MDSAP Experts | 1 min 35 secs |
Module 6: Benefits and Future of MDSAP
MDSAP Success Based on Multiple Factors | 1 min 01 secs |
Overall Benefits of MDSAP Implementation | 1 min 09 secs |
Manufacturer Benefits of MDSAP Implementation | 1 min 20 secs |
Advantages for MDSAP Participants | 1 min 16 secs |
Benefits for Each Country Participant | 1 min 18 secs |
Future of MDSAP | 1 min 09 secs |
MDSAP Drawbacks | 50 secs |
Challenges of MDSAP Participation | 1 min 11 secs |
Combating Industry Fears | 1 min 24 secs |
MDSAP Transition Plan Changes | 1 min 36 secs |
Conclusion
Final Assessment
Certification
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