Our Team
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Thirty-Four Standards Issued in One Day
November 29, 2024
268 IVD Classifications Released by NMPA
November 28, 2024
Our Leadership Team
Grace Fu Palma
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
Mark Wang
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
Iven Zuo
Principal
- 12 years of experience in national and Beijing NMPA
- Responsible for reviewing and approval of product technical and clinical registration, GMP and MAH licensing.
- Responsible for reviewing and approval of clinical trial compliance and audits. Performed many on-site audits.
- Experienced
- Performed many NMPA overseas inspections
- Participated developing and writing multiple NMPA technical review, clinical evaluation and trial regulations.
- PhD in biomedical engineering, Aerospace University
Ada Wang
Director of Regulatory
- 9+ years of experience in a wide range of medical device, SaMD, and IVD products in NMPA registration for both domestic and overseas products.
- Obtained 100+ approvals for Class II and Class III medical devices registration
- Specializing in active, SaMD and implants medical devices
Allan Yang
Director of Operations
- 15 years of experience in medical devices regulatory submissions, GMP, clinical evaluation and trial.
- Experienced in a wide range of active devices.
- Managed the complete product life at medical device manufacturing facility from product development to GMP/QMS to post market compliance
- MS in computer science, Aerospace University
Emma Li
Director of Testing Center
- 17 years of experience in Beijing Institute for Drug Control and Beijing Institute of Medical Device Testing with a wide range of medical devices and analytical instruments.
- Especially knowledgeable and experienced in medical device packaging and sterilization related technical requirements.
- Rich practical work experience in evaluating and performing chemical and microbiological tests.
- Regular speaker/instructor to educate industry on related technical standards and regulations
- MS in chemical engineering, Beijing Industrial University
Evan Zhan
Director of Testing Center
- 14 years of experience in the NMPA Beijing testing center and head of materials lab at the Beijing Medical Device Testing Center.
- Drafted and developed many of the medical device biosafety related industry standards.
- Designated subject expert and trainer in NMPA medical device related materials domain.
- Led and organized many training sessions to educate the industry on medical device industry technical standards
- BS in engineering, Chongqing University
