To support the development of the medical device industry, ITRI provides comprehensive regulatory science–based consulting and advisory services throughout the entire product life cycle.
These services are designed to help companies meet complex regulatory requirements within limited market timelines by leveraging ITRI’s accumulated expertise and experience in medical device regulations.
The goal is to shorten the time-to-market and regulatory approval process, thereby accelerating industry growth.
ITRI has successfully assisted numerous companies in obtaining product approvals in Taiwan, the United States, and the European Union (MDR/IVDR).
Based on the specific regulatory requirements for product market entry, ITRI offers a comprehensive, modularized regulatory support program, including:
Consultation and guidance on medical device market-entry regulations
Regulatory analysis and strategic planning for product registration
Regulatory education and training on product registration and quality system compliance
Preparation of regulatory submission documents, including:
product safety and efficacy documentation, risk assessment, clinical evaluation, software validation, cybersecurity, and human factors/usability engineering reports
Post-market surveillance planning and regulatory compliance advisory
何致緯
+886-3-5912520
Wendy_Ho@itri.org.tw