License Biomedical Co., LTD. is led by a team of professional consultants who possess over 15-year experience and passionate about medical device and auditing medical device.
We provide you certain services: registration of medical device under multiple countries. TFDA and QSD registration, ISO 13485 and GMP quality system guidance, clinical evaluation and testing, human factors engineering reports, risk management reports, software validation, and information security.
We provide you certain services: registration of medical device under multiple countries. TFDA and QSD registration, ISO 13485 and GMP quality system guidance, clinical evaluation and testing, human factors engineering reports, risk management reports, software validation, and information security.
License Biomedical Co., LTD. can help you receive the medical device registration quickly and guide you on entering the global market.
- Comprehensive Services
The team has a wide range of professional experience in medical device review, regulatory, manufacturing and clinical management review, etc., interdisciplinary professional practical experience. The consultant leads the clinical trial team and integrates a full set of solutions according to different regulatory requirements to improve service quality, efficiency and satisfaction.
- Global layout
We help our customers to apply for registration in Taiwan, the United States, European Union, China, Canada, Vietnam, southeast nations, Japan, South Korea, and other countries. Arranging the shortest time to complete the testing and documentation preparation, enabling your products enter the local market quickly. License Biomedical Co., LTD. is your first choice to explore the global market.
- 5S Management
Our enterprise spirits: Integrity, professionalism, and efficiency. To show the professionalism and highly added value, we implement 5S management in the working environment and results, wish to be beloved and to earn recognition and support from customers and business partners.