Ποιοτικός έλεγχος

At Snuke Medical, quality is not just a department—it's the foundation of every product we build. Our integrated quality management system, backed by international certifications and patented technologies, ensures that every endoscope camera delivering unparalleled reliability, safety, and performance from the production line to the operating room.

Our commitment to global standards is validated by the most stringent certifications in the medical device industry.

• ISO 13485:2016 Certified Manufacturing
  Our entire 3,500㎡ Shenzhen facility operates under the ISO 13485 quality management system, specifically designed for medical devices. This certifies that every process—from component sourcing to final packaging—meets the highest standards for consistency, traceability, and risk management.

• CE Marking & MDR 2017/745 Compliance
  Our products carry the CE Mark, demonstrating full compliance with the European Medical Device Regulation (MDR 2017/745). This signifies that Snuke cameras have undergone rigorous assessment for safety, performance, and clinical benefit, ensuring unrestricted market access in the European Union.

Our innovation is protected by a robust portfolio of patents, safeguarding the unique technologies that give our partners a competitive edge.

• Software Copyrights & Algorithm Patents

  • ClarityBoost™ Image Optimization Software (Copyrighted)

  • EndoVision OS Diagnostic Management Suite (Copyrighted)

  • Patented Image Optimization Algorithms (#2821835180175): Covers core processes for enhanced clarity and color accuracy.

  • Real-Time Tissue Tagging AI Patent: Protects our innovative intraoperative diagnostic assistance technology.

• Utility Model & Design Patents

  • Waterproofing Technology (Patent #CN 309337190 S): Covers the unique methodology for achieving IPX8/IPX67 sealing, a critical differentiator for device longevity and safety.

  • Industrial Design Patents: Protecting the ergonomic and aesthetic designs of our camera heads and control units, ensuring brand distinctiveness in the market.

Quality is engineered into every stage, validated by a multi-layered testing protocol.

• In-Process Quality Control (IPQC)

  • Automated Optical Inspection (AOI): Verifies solder joint integrity on every PCB.

  • Manual Micro-Welding Inspection: Skilled technicians perform checks under magnification.

• Final Product Validation & Traceability

  • Environmental Stress Testing: Thermal cycling (-20°C to 70°C) and 72-hour continuous operation tests.

  • Algorithm Checksum Audit: Ensures 100% software integrity for every deployed firmware.

  • Full UDI Logging & Audit Trails: As required by ISO 13485, providing complete traceability for every unit, from components to final customer.