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Regulatory Series Course: Medical Device Design and Development (Design Control) Quality System
Medical Device Design and Development (Design Controls) Quality System
Course Objectives
Understand how design activities should be conducted to meet design control requirements. Learn how to apply the specific contents of design documents in practice, and cultivate enthusiasm for design controls.
Course Content
USA 21 CFR 820.30
ISO 13485:2016, Section 7.3
User needs, design inputs, design planning, design outputs, design verification, design validation, design history file, design transfer, design changes.
Course Features
Focus on design controls, not a general quality management system course
Simplify complex design control regulatory requirements and explain them in plain language
Present design history file (DHF) and device master record (DMR) contents concretely
Use visuals to present each design control activity clearly, making it easy to understand
Course Information
Location: National Yang Ming Chiao Tung University, Yangming Campus, Biomedical Engineering Building, Room 101
Time: December 20 (Monday), 1:30 PM – 4:30 PM
