Risk Analysis – FMEAs Trainer: Mr. Vincent Cheung
Risk analysis is an integral part of the design control and risk management 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 and usability of devices, relationship with other quality system processes and consequences when risk analysis is not properly performed or untimely.
Day 1
Regulatory background (ISO 14971)
Methodology/Applications
Design FMEA
Common mistakes
Day 2
Application FMEA
Common mistakes
WHO SHOULD ATTEND?
Legal manufacturers, contract manufacturers, and/or specifications developers interested in bringing a new or modified medical device (implantable, IVD assays, electrical equipment, and disposables) to market. Typical job functions include but not limited to:
R&D
NPI Engineering
Quality (QMS, QA/QC, QE)
Manufacturing Engineering
Regulatory Compliance
Regulatory Affairs
Clinical Affairs
Available Workshops:
9 - 10 March 2020
Workshop Fee:
S$2400