Homer Wu, Ph.D.
Over 25+ years of experience in professional services, Dr. Wu is a visionary, seasoned, and dynamic professional, offering in-depth scientific, regulatory, and clinical knowledge of…
View profileHOPKINS MEDTECH COMPLIANCE
About Hopkins
MedTech Compliance.
An independent CRO and regulatory consulting partner for medical devices and in vitro diagnostics.
OUR COMPANY
Clinical research
and regulatory support.
Hopkins MedTech Compliance is an independent contract research organization (CRO) for medical devices and in vitro diagnostics (IVD). Operated by Hopkins MedTech Group LLC, a New Jersey limited liability company, we plan and run clinical performance studies and prepare the regulatory submissions that follow, for the United States (FDA) and the European Union.
Our focus connects clinical operations, regulatory affairs, clinical data and biostatistics, and quality and compliance. We also support Chinese companies considering US and European market entry.
Meet our team
THE ADVANTAGE OF EXPERTISE
The Hopkins MedTech Compliance helps medical device companies rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. HMC provides assistance in applying for EUA、 premarket notice 510K by FDA、 CE mark by European Commission and MDR.
HOW WE PARTNER
Our original
company introduction.
HMC supports clinical research, regulatory submission preparation and quality system work for medical device and in vitro diagnostic companies.
Read the original company materialsHistorical client statements
Statements published on the original website are preserved with the source records.
Read the original website recordsOUR TEAM
The HMC
team.
Jeff Wu
Co-founder of Hopkins MedTech Compliance. Ph.D. in Chemical Physics; earlier career at Johnson & Johnson and Arkema.
View profileJennifer Stanford
Director of Clinical OperationWendy Zhou, Ph.D.
Director of Laboratory ServicesAndrew Wayland
Director of Business DevelopmentQian Cheng, Ph.D.
Chief Biostatistician
CONTACT HMC
