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技术团队

  • Eric C,
    LEUNG

    PD Radiography, BA, MBA, ISO 13485 Lead Auditor
    EXPERIENCES
    Global GM, Health Sciences, UL
    SPECIALTIES
    MDR, 510k, DHF, DMR, CER, PMS, Sterilization, MDSAP

    Wei-Shan,
    HSU

    BSc., MSc., PhD, ISO 13485 Lead Auditor
    EXPERIENCES
    Experienced R&D Scientist
    SPECIALTIES
    MDR, 510k, DHF, DMR, CER, PMS, Sterilization, MDSAP

    Angela,
    HUO

    MD, ISO 13485 Lead Auditor
    EXPERIENCES
    Resident Doctor, Nutrition Specialist
    SPECIALTIES
    MDR, CER, QMS, MDSAP

  • Ivy,
    LAI

    BSc., MSc., ISO 13485 Lead Auditor
    EXPERIENCES
    Seasoned Regulatory Specialist
    SPECIALTIES
    TFDA, MDR, 510k, RM & QMS

    Kath,
    AU

    BA, MA, ISO 13485 Lead Auditor
    EXPERIENCES
    QMS, HKMDD Listing
    SPECIALTIES
    QMS, HKMDD Listing

    Evie,
    CHEN

    BSc.,MEng, ISO 13485 Lead Auditor
    EXPERIENCES
    Seasoned Regulatory Specialist
    SPECIALTIES
    HKMDD, ISO 13485, Sterilization, MDSAP

  • Zhuo Ying,
    HUANG

    B. Pharmacy, ISO 13485 Lead Auditor
    EXPERIENCES
    Seasoned Regulatory Specialist
    SPECIALTIES
    HKMDD, ISO 13485, Sterilization, MDSAP

    Zoe,
    CHEN

    BSc., ISO 13485 Lead Auditor
    EXPERIENCES
    Seasoned Regulatory Specialist
    SPECIALTIES
    TFDA, MDR, 510k, RM & QMS

    Paul,
    CHAN

    BEng., ISO 13485 Lead Auditor
    EXPERIENCES
    Global GM, Health Sciences, UL
    SPECIALTIES
    Global Market Access, Laboratory
    Startup

  • Kacia,
    Mak

    BEng, MEng, ISO 13485 Lead Auditor, 6-Sigma Black Belt
    EXPERIENCES
    Seasoned Design/Quality Engineer
    SPECIALTIES
    Active Devices, Statistics, Software & Cybersecurity

    Tina,
    Ma

    BSc, MSc
    EXPERIENCES
    Radiological Sciences
    SPECIALTIES
    TFDA, GDP

    Rin,
    Lu

    B.Ethn.
    EXPERIENCES
    Regulatory Services
    SPECIALTIES
    TFDA, Cosmetics