logo
aboutus
Home > About Us>

Hunan Endovascular Device Co., Ltd. Quality Control
QC Profile
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
Certification
Contact Details