Risk Analysis – FMEAs Trainer: Mr. Vincent Cheung
Risk analysis is an integral part of the design control process. Participants will learn “how-to” construct, evaluate, estimate, and control risks from a device design (dFMEA) and application (aFMEA) perspective using actual marketed medical device products. Participants will also learn common mistakes, pitfalls, relationship between design, usability, and production of device, relationship with other quality system processes and consequences when risk analysis is not properly performed.
Day 1
Regulatory background (ISO 14971)
Methodology/Applications
Design FMEA
Common mistakes
Day 2
Application FMEA
Process FMEA
Common mistakes
WHO SHOULD ATTEND?
Personnel from finished product manufacturers, contract manufacturers, and/or specifications developers interested in bringing a new or modified medical device to market. Typical job functions include but not limited to:
R&D
NPI
Manufacturing Engineering
Process Engineering
Quality Engineering
QA/QC
Regulatory Affairs
Clinical Affairs
Available Workshops:
13 - 14 May 2019
Workshop Fee:
S$2100