Design Control Trainer: Mr. Vincent Cheung
Design control is a global regulatory requirement that must be fulfilled before any device premarket applications (US PMA, 510(k), CE Mark, etc) are 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.
Day 1
Regulatory requirements (21 CFR Part 820, ISO 13485)
Design planning
Design inputs and outputs
Consideration of risk analysis
Common statistical techniques
Design verification
Design reviews
Common mistakes
Day 2
Manufacturing readiness
Design validations
Design transfer
Design changes
Design history file
Common mistakes
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:
Manufacturing Engineering
Process Engineering
Quality Engineering
Regulatory Affairs
Clinical Affairs
Project Management
Available Workshops:
3 - 4 June 2019
Workshop Fee: