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