Medical Device Change Control
DATE: 3-4 December 2025
TIME: 9.00am – 5.15pm
VENUE: Ascott Gurney 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 change control for medical
devices.
COURSE OUTLINE
1. Introduction to medical device change control
2. Change control – ISO and regulatory requirements
3. Changes/ modification to medical devices
4. Medical device change control and risk management
5. Implementing change control process
6. Good documentation practices
COURSE FEES (8% SST included)
Early Bird Price (until 12 November 2025)
Member: RM 1,998.00
Public: RM 2,214.00
Normal Price (from 13 November 2025 onwards)
Member: RM 2,214.00
Public: RM 2,430.00
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
Sdn. Bhd)
Zeito Plastic Components Sdn Bhd
www.dexcom.com
