Quality System Management counseling
- ISO13485&GMP system counseling
- QSD/GDP Certification Services
- Internal audit counseling
- Advisory expert of IRB in three medical centers, University of Science and Technology, Taiwan Medical Care Assistive Technologies Association and Taiwan Federation of Medical Devices Commercial Association.
- Extensive experience in applying certificate of registration from CE and multi-national health administration.
- Member of Medical Device Registration(TFDA and CDE) and Institutional Review Board (IRB) over 15 years.
- More than 10 years experience in Medical Device clinical investigations practical.
Atomic Energy Council Radiation Protection Personnel Certificate
ISO 13485/14001 Lead Auditor
License consultant