Eligible for TFDA Continuing Education Credits for Medical Device Technicians upon completion.
[Sessions 3] Next-Generation Radiation Sterilizers and Process Validation
Date & Time: May 26, 2026 (Tue.) | 09:00 – 17:00
Chien-Jung Kuo (Vice President of Shin-Ho Biotech Co., Ltd.)
Course Coverage:▪ Medical Device Sterilization Validation
▪ Biosafety and Quality Risk Management
▪ Packaging Validation and Shelf-life Determination
▪ Global Market Clearance and Regulatory Planning
Instructor Expertise:Medical device quality systems and risk management; sterilization validation and biosafety; packaging validation and shelf-life determination; global market clearance and regulatory planning; and animal efficacy study planning.
National Yang Ming Chiao Tung University (Beitou Campus)
Hybrid: In-person + Online synchronous In-person Course Online Course [Sessions 4] User Evaluation (IEC 62366) and Human Factors Engineering Date & Time: May 29, 2026 (Fri.) | 09:00 – 17:00 Section Chief Liu, Biomedical Regulatory Affairs Section, Medical Device Department, Plastics Industry Development Center (PIDC) Course Coverage:▪ IEC 62366 User Evaluation
▪ Human Factors and Usability Planning
▪ Regulatory Requirements for Medical Devices
▪ Practical Case Studies and Analysis
Instructor Expertise:Medical device quality management systems, product registration, medical device regulations, and industrial consultancy planning.
National Yang Ming Chiao Tung University (Beitou Campus) Hybrid: In-person + Online synchronous In-person Course 