Quality Control
Quality Assurance & Regulatory Compliance
Manufacturing Excellence
- Full vertical integration ensures end-to-end quality control from raw materials to finished devices
- ISO 13485:2016 certified by TÜV SÜD (quality management system)
- CE-MDR (2017/745) upgrade underway (anticipated Q1 2025) with TÜV SÜD as notified body
- 24 products approved under China NMPA medical device registration
Clinical Validation
- 15+ years of specialized nephrostomy device manufacturing expertise
- 12 clinical studies demonstrating safety and efficacy (data available upon request)
- Documented 98.2% first-attempt success rate across 2,300+ PCNL procedures
Continuous Quality Commitment
- Quarterly ISO 10993 biocompatibility testing protocol
- 100% real-time needle sharpness verification during production
- Dedicated MDR transition team implementing enhanced post-market surveillance
Competitive Advantages
- Single-source manufacturing ensures supply chain security
- Dual regulatory compliance (24 NMPA approvals + ISO 13485)
- Active FDA 510(k) preparation for Q2 2025 submission
Certifications
Standard:
ISO-13485
Number:
Scope/Range:
Issued By:
Standard:
lzin Distribusi Alat Kesehatan
Number:
20805520377
Expiry Date:
2030-04-28
Scope/Range:
Ureteral Access Sheath
Issued By:
PEMERINTAH REPUBLIK INDONESIA
Company Profile
Hunan Endovascular Device Co., Ltd.
Contact Person: MrSales Office Manager
