
Risk Management for Medical Devices (EN ISO14971:2019)
DATE: 29-30 September 2025
TIME: 9.00am – 5.15pm
VENUE: Ascott Gurney Hotel Penang
DURATION: 2 full-day course
COURSE OBJECTIVES
This training aims to provide participants with a clear understanding and insight into the EN ISO
14971:2019/ A11:2021 requirements. The training takes a look at the major changes in the 2019
update/revision and also covers some of the commonly used risk management tools such as FMEA,
FTA, etc.
COURSE OUTLINE
1. Basic principles of risk management
2. EN ISO 14971:2019/ A11:2021 requirements
3. ISO 14971:2007 vs ISO 14971:2019
4. Changes in ISO/TR 24971:2020
5. Summary of what need to be done to meet EN ISO 14971:2019/ A11:2021 requirements
DURATION
Two (2) full days
MODE OF TRAINING
Classroom Training
COURSE FEES (8% SST included)
Early Bird Price (until 8 September 2025)
Member: RM 1,998.00
Public: RM 2,214.00
Normal Price (from 9 September 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