24-25 September 2025: Medical Device Single Audit Program

Medical Device Single Audit Program

DATE: 24-25 September 2025

TIME: 9.00am – 5.15pm

VENUE:  G Hotel Gurney, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
After participating in the training, you will be able to:
• Learn the structure and purpose of Medical Device Single Audit Program (MDSAP)
• Gain a good understanding of the seven processes in MDSAP and their interlinkages.
• Learn the MDSAP audit approach.
• Understand the MDSAP certification process.

COURSE OUTLINE
1. Background of the MDSAP
2. MDSAP members, official observers, and affiliate members
3. The seven processes in MDSAP
4. Chapter 1 – Management
5. Chapter 2 – Device Marketing Authorization and Facility Registration
6. Chapter 3 – Measurement, Analysis and Improvement
7. Chapter 4 – Medical Device Adverse Events and Advisory Notices Reporting
8. Chapter 5 – Design and Development
9. Chapter 6 – Production and Service Controls
10. Chapter 7 – Purchasing
11. Auditing Organization (AO) and MDSAP certification
12. The MDSAP audit approach and audit time determination

CONTACT
For enquiries, please email to Medsociate Sdn Bhd.
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194