Services
We offer a comprehensive range of services in the field of medical device regulatory affairs and provide extensive regulatory support in various ways. Our services are designed to assist you at every stage of the regulatory process, ensuring compliance with the applicable regulations and standards.
Comprehensive Medical Device Regulatory Consulting
Tailored Solutions for Short, Medium, and Long-term Needs
QMS Compliance
ISO 13485
Mock Audit
EN ISO 13485
Post-market Surveillance
Mock Audit
Taiwan FDA Quality Management System (QMS)
Taiwan FDA Good Distribution Practice (GDP)
US FDA 21 CFR Part 820 (QSR) / Quality Management System Regulation (QMSR)
Medical Device Single Audit Program (MDSAP)
Medical Device Compliance
US FDA
Registration and Listing
510(k)
Premarket Approval (PMA)
513(g) Request
De Novo Classification Request
Taiwan FDA
Taiwan Agent
Class I, II, III Registration
QSD for Import Product
Medical Device Classification Request
European CE Marking
CE MDR Marking
CE IVDR Marking
MDR Gap Analysis
IVDR Gap Analysis
Person Responsible for Regulatory Compliance
Compliance with MDR or IVDR QMS Mock Audit
Health Canada
Medical Device Establishment License (MDEL) for Class I
Medical Device License (MDL) for Class II, III, and IV
Technical Documentation Writing/Assisting Service
Risk Management Report (Compliance with ISO 14971, ISO/TR 24971)
Usability Evaluation Report (Compliance with IEC 60601-1-6, IEC 62366)
Medical Device Software Verification Report (Compliance with IEC 62304, IEC 82304)
Clinical Evaluation Report (Compliance with MDR)
Performance Evaluation Report (Compliance with IVDR)
Biological Testing Evaluation Report (Compliance with ISO 10993-1:2018)
EU CE Technical Documentation (TD)
Performance Testing Report
Others
US FDA Small Business Qualification Certification Assistance