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.
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:
Available Workshops:
Please contact AQS Labs.
Workshop Fee:
S$2400