Medical Device Single Audit Program (MDSAP) – Part 3


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:
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
Final Assessment

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