Due to the variety of medical devices, the device classification is determined in accordance with its risk level which depends on the intended use, duration of use, and body position of contact of each device. The internationally recognized regulation/standard of the quality management system (QMS) of device mostly follow the ISO 13485 requirements at present. In additional to the QMS requirements, the management strategy and regulatory requirements of the medical device stipulated by each country are different. Therefore, in terms of the product registration of medical device in various countries, it is necessary to customize the corresponding regulatory compliance of each case and plan a comprehensive strategy of the registration.

In order to support the domestic medical device industry, our center can provide the counseling and regulatory service on the compliance of relevant regulations, technical consultation, clinical evaluation/clinical trial research, and the product registration.

Our regulatory service:

1.Counseling service for the quality system management of medical devices, including QMS/QSD/ISO13485, MDR/IVDR gap analysis, FDA QSR gap analysis.

2.Regulatory service for technical documentation preparation of medical devices, including usability, clinical evaluation, risk management, post-market surveillance and TCF compiling.

3.Clinical service for clinical trial planning, conduction, and hospital/investigator matchmaking.

4.Regulatory submission for the domestic and foreign countries, including Taiwan (QMS/QSD/GDP/product registration), European (MDR/IVDR), America (FDA 510K) and other overseas countries.