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

  1. Mock Audit

  • EN ISO 13485

  1. Post-market Surveillance

  2. Mock Audit

  • Taiwan FDA Good Manufacturing Practice (GMP)

  • US FDA 21 CFR Part 820 (QSR)

  • Medical Device Single Audit Program (MDSAP)

  • Good Distribution Practice (GDP)

Device Registration

  • US FDA

  1. Registration and Listing

  2. 510(k)

  3. Premarket Approval (PMA)

  • Taiwan FDA

  1. Taiwan Agent

  2. Class I, II, III Registration

  3. QSD

  • European CE Marking

  1. CE MDR Marking

  2. CE IVDR Marking

  3. MDD vs. MDR Gap Analysis

  4. IVDD vs. IVDR Gap Analysis

  5. Person Responsible for Regulatory Compliance

  6. Compliance with MDR or IVDR QMS Mock Audit

  • Health Canada

Technical Documentation Writing/Assisting Service

  • Risk Management Report (ISO 14971, ISO/TR 24971)

  • Usability Evaluation Report (IEC 60601-1-6, IEC 62366)

  • Medical Device Software Verification (IEC 62304, IEC 82304)

  • Clinical Evaluation Report (MEDDEV 2.7/1 revision 4, Compliance with MDR)

  • Biological Testing Evaluation Report (ISO 10993-1:2018)

  • EU CE Technical Documentation (TD)

  • Performance Testing Report

Others

  • US FDA Small Business Qualification Certification Assistance

  • Taiwan FDA Cosmeceuticals Registration