Medical Device Design Control
DATE: 28 & 29 Sep 2026
TIME: 9.00am – 5.15pm
VENUE: Iconic Marjorie Hotel, Penang
DURATION: 2 full-day course
COURSE OBJECTIVES
This course provides quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills to implement design control for medical devices.
COURSE OUTLINE
1. Introduction to design control
2. Application of risk management to design control
3. Design control system
- Design and development planning
- Design and development input
- Design and development output
- Design and development review
- Design and development verification
- Design and Development validation
- Design and development transfer
- Design and development changes
- Design history file
4. Validation system (Design/Installation/Operational and Performance Qualification)
5. Statistical tools and techniques
6. Design control – Quality system inspection technique
COURSE FEES (8% SST included)
Early Bird Price (until 7 Sep 2026)
AMMI Member: RM 1,998.00
Public: RM 2,214.00
Normal Price (from 8 Sep 2026 onwards)
AMMI Member: RM 2,214.00
Public: RM 2,430.00
Bonus deal for group registration
For the 6th pax to 9th pax: 30% discount
For the 10th pax & above: 75% discount
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
Zeito Plastic Components Sdn Bhd
www.dexcom.com
