23 – 24 June 2026: Failure Mode and Effects Analysis (FMEA) in Medical Device Manufacturing

Failure Mode and Effects Analysis (FMEA) in Medical Device Manufacturing

DATE: 23 & 24 June 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

INTRODUCTION
This training course is designed specifically to equip professionals with the knowledge and skills needed to navigate the complex landscape of risk and compliance through an innovative and revamp approach on application of Failure Mode and Effects Analysis (FMEA) with a unified criteria framework. Join us as we delve into practical methodologies that foster a holistic understanding of integrated risk assessment, ensuring effective compliance measures in a dynamic medical device industry.

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

• Learn the practical methodologies for applying reformed Failure Mode and Effects Analysis (FMEA) techniques in diverse business scenarios.
• Gain a deep understanding of the integrated risk landscape and its implications for compliance.
• Learn how to develop a rating table that addresses all pillars of risk.
• Use advance FMEA to determine Critical Product Attributes and Critical Process Attributes for subsequent validation and control activities.
• Develop the ability to identify, assess, and prioritize risks within a unified criteria framework.

COURSE OUTLINE
1. What is FMEA?
2. FMEA history
3. FMEA benefits
4. FMEA challenges
5. When FMEA is needed?
6. Types of FMEA
7. DFMEA vs PFMEA
8. Murphy’s Law
9. Product cycle
10. Terms and definitions
11. Steps in FMEA process
12. Input for DFMEA & PFMEA
13. Process flowchart / map
14. Conventional FMEA weakness
15. Advance FMEA (AFMEA)
16. Understanding & filling of FMEA template
17. FMEA rating & acceptance criteria: Conventional vs. True
18. Pillar of risk – Integrated risk compliance to ISO 13485:2016, ISO 14971:2019, FDA QSR & EU MDR
19. Investigation tools
20. 7 Things on FMEAs
21. Top 10 mistakes made when apply FMEA
22. Relationship between FMEA vs. validation vs. control plan
23. AFMEA for Critical Product Attributes (CPAs) and Critical Process Attributes (CRAs)
24. List of other risk assessment tools & techniques