Principal Medical Device Consultant
ex-FDA device reviewer
Dr. Chen has more than 15 years’ experience combined at FDA as a reviewer and team leader at CDRH, FDA and industry experiences at Boston Scientific, Endocare, Varian Medical Systems, Genetron Health and MicroDiag Biomedicine.Technical Expertise
- Knowledge and experience in regulatory requirements and pathways for
premarket review including 510(k), PMA, IDE, HDE and De Novo.
- Reviewer of premarket PMA review team and oversee medical device
post-approval and post-market surveillance studies.
- FDA’s regulatory strategies for medical devices.
- Real-world study in medical device evaluation.
- Combination (Drug-Device) products regulation.
- Medical device risk management.
- Clinical evidence requirements for medical device approvals by FDA.
- Clinical evaluation to support the registration of new medical device
- Knowledge and experience in medical device classification/regulations and
- Knowledge and experience in FDA available resources to help prepare the
premarket submissions including 513(g) Device Classification Request,
Pre-Submission (Q-sub), Breakthrough Devices Designation Application.
- Knowledge in FDA’s Medical Device Compliance Programs.
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