Practical Application of Design Control for Medical Devices Trainer: Mr. Vincent Cheung
Design control is a quality management system requirement (EN/ISO 13485, 21 CFR Part 820) that is applicable to all medical devices regardless of their classification. The evidential information generated is used to prepare technical documentation required for regulatory submissions such as CE marking, premarket notification (510k), Premarket Approval (PMA), and ASEAN CSDT product registration. Trainees will learn real-world application of the design control process with the focus on “how-to” bring a medical device through different design and development stages efficiently and effectively. The interrelationship with other applicable regulatory requirements such as risk management (ISO 14971), software development (IEC 62304), biocompatibility (ISO 10993), usability engineering (IEC 62366), and other product safety testing will be discussed. Trainees will also learn the practical methods of establishing and maintaining documentation for design planning, design input requirements, design outputs, sample size determination, test protocols/reports, design verification testing, statistical data analysis, design validation including clinical evaluations, and design change management.
Day 1
Regulatory expectations (21 CFR Part 820, ISO 13485)
Design planning
Design inputs (group activity)
Design outputs (group activity)
Application of risk management process
Design verification testing strategies
Sample size determination (group activity)
Statistical data analysis
Design reviews
Common mistakes
Day 2
Pre-production activities and documentation
Design validations
Design transfer
Design changes
Design history file
Common mistakes
Training evaluation
Any organizations or person(s) interested in bringing a new or modified medical device to market. Typical job functions include but not limited to:
Project Managers
NPI Engineers
Quality (QMS, QE)
Software Engineers
Manufacturing Engineers
Regulatory Affairs
Available Workshops:
Please contact AQS Labs.
Workshop Fee: