26-27 May 2025: Failure Mode and Effects Analysis (FMEA) in Medical Device Manufacturing

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

DATE: 26-27 May 2025

TIME: 9.00am – 5.15pm

VENUE: Ascott Gurney Hotel Penang

DURATION: 2 full-day course

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. The history, benefits and challenges of FMEA
2. When FMEA is needed?
3. Type of FMEAs
4. Design FMEA vs Process FMEA
5. Steps in FMEA process
6. Input for DFMEA & PFMEA
7. Process flowchart / map
8. Conventional FMEA weakness
9. Advance FMEA (AFMEA)
10. Understanding & filling of FMEA template
11. FMEA rating & acceptance criteria: Conventional vs True
12. Pillar of risk – Integrated risk compliance to ISO 13485:2016, ISO 14971:2019, FDA QSR & EU
13. MDR
14. Investigation tools
15. Top 10 mistakes made when apply FMEA
16. Relationship between FMEA vs Validation vs Control Plan
17. AFMEA for Critical Product Attributes and Critical Process Attributes
18. Other risk assessment tools & techniques

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