Trainer: Mr. Vincent Cheung
Design control is a global regulatory requirement that must be fulfilled before any device premarket applications (e.g. US, EU, Singapore, etc) can be submitted. Participants will learn “how-to” construct design plans, design input requirements, design verification test protocols/reports including the use of risk-based sample size determination and statistical techniques, and discuss the importance of other relevant verification & validation activities (e.g. biocompatibility, usability, aging, sterilization, process validations), device master record, design history file, design reviews, and design changes. Participants will also learn common mistakes, pitfalls, relationship with other quality system processes and consequences when design control is not properly performed.
Legal manufacturers, contract manufacturers, and/or specifications developers interested in bringing a new or modified medical device (implantable, IVD assays, electrical equipment, standalone software (SaMD) and disposables) to market. Typical job functions include but not limited to:
Available Workshops:
Please contact AQS Labs.
Workshop Fee:
S$2400