The Team

A global network of experts in medical device registration, QMS, and sales.

Founder

Haley Li

Guangzhou, China

Medical device CRO & Notified Body sales & Translator (Mandarin, English & Japanese).

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Jun

NMPA Medical Device Registration Manager

Beijing, China

Expert in NMPA registration since 2008. Past experience includes GE, Edwards Lifesciences, ZEISS, and ZOLL Medical.

Klem

Medical Device CE, FDA & QMS Manager

Guangzhou, China

Specialist in NMPA, ISO 13485, MDSAP since 2012. Extensive experience with Chinese manufacturers & CROs.

Cindy

Senior Registration Manager (NMPA, CE & FDA)

Munich, Germany

Industry veteran since 2002. Past experience includes Cochlear, Bausch & Lomb, joimax, and Galderma.

Shawn

Head of U.S. Subsidiary

High Point, NC, USA

Seasoned business development and clinical project management expert with 15+ years in pharma and medical devices, specializing in U.S., EU, and LATAM medical product registration, clinical trial, and commercialization. Experienced in leading cross-border clinical trials (U.S./EU), serving as U.S. Agent for FDA registrations, and identifying strategic distributors to support market entry. Strong cross-cultural expertise from working in both the U.S. and China.