Services

We assist you a wide range of services about medical device regulatory, and provide regulatory support in multiple ways:
  • Regulatory Consulting Services

  • QMS Compliance
    • ISO 13485
    • Good Manufacturing Practice (GMP)
    • 21 CFR Part 820 (QSR)
    • Medical Device Single Audit Program (MDSAP)
    • Good Distribution Practice (GDP)

  • Device Registration 
    • US FDA
      • Registration and Listing
      • 510(k)
      • Premarket Approval (PMA)
    • Taiwan FDA
      • Taiwan Agent
      • Class I, II, III Registration
      • QSD
    • European CE Marking
      • MDD vs. MDR Gap Analysis
      • IVDD vs. IVDR Gap Analysis
    • Health Canada
  • Medical Device Technical Documentation Service
    • Risk Management Report (ISO 14971)
    • Usability Evaluation Report (IEC 62366)
    • Medical  Device  Software  Verification (IEC 62304, IEC 82304)
    • Clinical Evaluation Report(MEDDEV 2.7/1 revision 4)
    • Biological Testing Evaluation Report (ISO 10993-1:2018)
    • Performance Testing Report
    • EU Technical Documentation (TD)
  • Others
    • US FDA Small Business Qualification Certification Assistance
    • Taiwan  FDA  Cosmeceuticals  Registration