Quality & Compliance
MARGE maintains the highest standards of quality management, certified to international medical device regulations.
ISO 13485:2016 Certified
Certificate Number: CN24/00005834
Issuing Body: SGS United Kingdom Ltd.
Valid: 2024-09-14 to 2027-09-13
Our Quality Management System
From raw material procurement to finished product delivery, MARGE maintains a comprehensive quality management system covering:
- Supplier qualification — All raw material suppliers audited and approved
- Incoming inspection — 100% incoming material inspection
- In-process control — Statistical process control (SPC) at critical stages
- Final testing — Performance, electrical safety, and EMC testing
- Traceability — Full serial number tracking from raw material to delivery
Certifications & Compliance
| Certification | Status | Details |
|---|---|---|
| ISO 13485:2016 | ✅ Certified | SGS UK, valid to 2027-09-13 |
| China Class II Medical Device Production License | ✅ Licensed | 粤食药监械生产许20183155 |
| Disinfection Equipment Production/Sales License | ✅ Licensed | Per Chinese regulations |
| High-tech Enterprise | ✅ Certified | 2025 designation |
| Specialized & Sophisticated SME | ✅ Provincial | Specialized & new SME |
| CE Marking (EU) | 🟡 In Progress | Currently being obtained for key SKUs |
| UAE MOHAP Registration | 🟡 In Progress | For Middle East market entry |
Download Compliance Documents
Authorized partners can request the following documents:
- ISO 13485 Certificate (PDF)
- Product Test Reports
- Declaration of Conformity
- Material Safety Data Sheets (MSDS) for cleaning agents