
ISO 13485: 2016 Quality Management System
DATE: 8 & 9 October 2025
TIME: 9.00am – 5.15pm
PLATFORM: Online via Zoom
DURATION: 2 full-day course
COURSE OBJECTIVES
After participating in the training, you will be able to:
• Understand what a medical device is.
• Understand and interpret the ISO 13485:2016 requirements.
• Learn the practical implementation examples.
COURSE OUTLINE
1. Introduction to medical device
2. The purpose of ISO 13485
3. Clause 1: Scope
4. Clause 2: Normative References
5. Clause 3: Terms and Definitions
6. Clause 4: Quality Management System
7. Clause 5: Management Responsibility
8. Clause 6: Resource Management
9. Clause 7: Product Realization
10. Clause 8: Measurement, Analysis and Improvement
DURATION
Two (2) full days
MODE OF TRAINING
Online Training
COURSE FEES
Early Bird Price (until 17 September 2025)
Member (Early Bird) RM 1 ,652.40
Public (Early Bird) RM 1,868.40
Normal Price (from 18 September 2025 onwards)
Member: RM 1,868.40
Public: RM 2,084.40
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