Understanding and Implementing Medical Device Single Audit Programme (MDSAP)

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3049

Course Title:
Understanding & Implementing Medical Device Single Audit Program (MDSAP)

Duration:
2 Days

Target Group:
Managers, Engineers, Internal Auditors and Exempt-staffs.

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in Understanding & Implementing Medical Device Single Audit Program (MDSAP) by the Association of Malaysian Medical Industries

Course Objectives:
The MDSAP (Medical Device Single Audit Program) is an audit program where a medical device manufacturer’s QMS to be audited once by an Audit Organization for compliance with the ISO 13485:2016 and up to five country-specific (Australia, Brazil, Canada, Japan and the United States).  This course is designed to provide participants with the practical knowledge to understand and implement the MDSAP requirements. The program enables appropriate regulatory oversight of medical device manufacturers’ QMS by the Regulatory Authorities while minimizing regulatory burden on the medical devices industry.

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

Course Content:

  1. Introduction to MDSAP
  2. Understanding the Audit Criteria of Management Process
  3. Understanding the Audit Criteria of Device Marketing Authorization & Facility Registration Process
  4. Understanding the Audit Criteria of Measurement, Analysis & Improvement Process
  5. Understanding the Audit Criteria of Medical Device Adverse Events & Advisory Notices Reporting Process
  6. Understanding the Audit Criteria of Design & Development Process
  7. Understanding the Audit Criteria of Production & Service Controls Process
  8. Understanding the Audit Criteria of Purchasing Process
  9. Implementing MDSAP Audit Model

Learning Outcomes:
By the end of this course, participants will be able to:

  • Understand the MDSAP requirements, the Audit Model & Sequence, and the details Audit Tasks for the primary MDSAP processes and the supporting processes.
  • Implement MDSAP Audit Model during internal audit.