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Overseas Inspection in 2024: Rise of Remote GMP Audits
March 24, 2025
NMPA Roundup March 2025
March 11, 2025
Our Leadership Team
Grace P
Principal
- 20+ years of experience driving product strategy, regulatory approval, business and channels partnership and market development for both large multinationals and startup companies
- Bi-lingual, bi-cultural and deep MedTech connections and practical knowledge and experience in China
- Founder of Chinese American Heart Association (CnAHA) in 2005
- Member of AdvaMed International Committee, and RAPS Education Committee
- Speaker/trainer/writer for regulatory and clinical affairs meetings and MedTech companies
Zeus Z
Principal
- 20+ year of experience in healthcare industry
- 15+ years of experience as invasive cardiologist at Level III hospital in 1st-tier city
- Led and managed the development, manufacturing, and commercialization of several class III medical polymer products for various surgical procedures and implants
- Advisor to big China JV and investment banks to evaluate the investment portfolio
- MD, China Capital Medical University
Mark W
Principal
- 14 years of experience in national and Beijing NMPA
- Reviewed and approved numerous product registrations
- Reviewed, conducted and approved medical devices manufacturers GMP licensing that covers the entire GMP requirements
- Audited and inspected medical device manufacturers’ manufacturing processes, unannounced inspection at domestic manufacturers sites as well as multiple overseas inspection as part of the NMPA team
- Participated in developing and writing NMPA GMP and technical standards
- MS in biomedical engineering, China National Science Academy
BG Q
Principal
- 10 years’ experience in TUV China as RA manager, Technical Certifier, Trainer for ISO13485 and MDD 93/42/EEC, Lead auditor of ISO 13485/ MDD 93/42/EEC, JGMP
- Served 30+ China companies and other foreign manufacturers such as Sysmex, MBL, FUJI etc.
- More than 1000 times audit experience
- Product expert and test engineer for monitoring devices, software, MRI etc.
- Ex- NMPA technical reviewer for imported and Class III medical device
Vin W
Clinical Director
- Over 17 years experiences in China healthcare industry. Cardiologist by training.
- Led and completed 100+ clinical trials for medical device /IVD registration in China.
- Established relationships with 100+ clinical trial sites/hospitals and several hundred PIs.
- Deep knowledge in China medical device/IVD clinical evidence and trial requirements for both domestic and imported medical devices and genetic testing.
- Seasoned practical experience in the entire CRO process from clinical trial protocol, EC approval, patients recruit, CRA/CRC monitoring, data collection, reporting, clinical trial audits etc. in both medical device and IVDs.
- Products include: IOLs, Glaucoma Implants, Orthopedic implants, PET/CT, Energy based aesthetic devices, fillers surgical sealant, drug diluted stents, IVD/CDx etc a wide range of devices in ophthalmology, aesthetics, cardiovascular and surgery indications.
- Certified and experienced in auditing and inspecting clinical trial quality for regulatory and GCP compliance.
Yan S
CER Writer & PM
- Written multiple CER reports for different types of medical devices (e.g., implants, IVF media, imaging etc)
- Registration clinical evaluation planning and strategy: NMPA registration pathway analysis, construction of overall clinical evaluation pathways for different devices and IVDs
- Prepared and participated at multiple pre-submission consultations with China NMPA CMDE to support predicate CER, none-predicate CER, overseas clinical trial data, etc.
- Managed and supported regulatory submissions and clinical trial projects for implant devices
- PhD, in Pharmaceutical Sciences, Oregon State University, BS, Shenyang Pharmaceutical University
Lesly X
CER Writer & CT
- Registration clinical evaluation planning and strategy: NMPA, CE registration pathway analysis, construction of overall clinical evaluation pathways
- CER feasibility evaluation with clinical and none-clinical evidence from the manufacturer documents. Evaluated a wide range devices’ design history files , clinical practice guidelines, risk benefit management, IFU etc.
- CER Writing, Clinical Trials/PMCF (CIP, IB, ICF, CRF, CSR, etc.) writing.
- Meta-analysis: literature search and screening, medical writing.
- Regulatory consultation for MDR and NMPA clinical evaluation.
- Experienced in collecting, sorting and analyzing the current knowledge/state of the art in the corresponding medical field and the information of equivalent device.
- MS, Bioengineering, China Science Academy-Bioengineering Research. BS, Bioengineering, SuZhou Univeristy
Laura L
Principal of Regulatory Affairs
- Over 15 years of cross functional management experience on registration and R&D.
- R&D documents drafting, new project R&D complete process implementation and management.
- CE marking and NB change for active, passive device, and software product.
- Registration planning and strategy: registration pathway analysis, overall pathway planning for global market release.
- Regulatory registration consultation for APAC countries, and for MDR and NMPA clinical evaluation.
- CER writing and independent project management.
- BS, Material Forming and Control Engineering, Wuhan Engineering University.