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Risk Management for Medical Devices (EN ISO14971:2019)

DATE: 22-23  October 2025

TIME: 9.00am – 5.15pm

VENUE: Ascott Gurney 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

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

ISO 13485: 2016 Quality Management System

DATE: 8 & 9 October 2025

TIME: 9.00am – 5.30pm

VENUE: Ascott Gurney Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES

After participating in the training, you will be able to:

• Understand the overarching concepts used in ISO 13485.
• Understand and interpret the ISO 13485:2016 requirements.
• Strengthen and enhance the quality management system implementation, practices and gap improvement actions.

COURSE OUTLINE

1. Overview on ISO 13485:2016 and the ISO/ TC 210
2. Clause 0.2: Clarification of Concept
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

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