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Get in touch with DH Regsys

DH Regsys

DH RegSys are focused on providing consultancy services for the medical device industry, with a forté being consulting for Quality Management Systems (QMS) and Regulatory Affairs. They also provide training for QMS and Regulatory Affairs.

Main services by DH RegSys

Others

  • Risk Management Consulting Services (ISO14971)

  • Software Life Cycle (IEC 62304)

  • Usability Studies

  • Regulatory Advice to Support Clinical Trials

QMS Consulting

  • International Organization for Standardization ISO13485

  • 21 CFR Part 820 Quality System Regulation

  • Good Distribution Practice for Medical Devices (GDPMD)

Regulatory Affairs Consulting

A wide array of Medical Devices

  • General Medical DevicesSingle-use Devices
    Implants
    Sterile Devices
    Electro-mechanical Devices

  • In Vitro Diagnostics (IVD)Test kits

  • Software Systems

Wide Global Coverage

  • ASEAN Countries ​

  • Australia: Therapeutic Goods Administration (TGA)

  • China

  • Europe: Conformité Européenne (CE) Medical Device Regulation (MDR) / In Vitro Diagnostic Regulation (IVDR)

  • Japan

  • South Korea

  • United States of America: Food and Drug Administration (FDA)

Training

  • Quality Management Systems

  • Regulations

  • Risk management

  • Design & development

  • V&V

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