Quality Assurance

Quality System

  • ISO13485:2016 quality management system
  • Document-controlled process from incoming material to final release
  • Lot-level traceability for materials and production records

Inspection Control

  • Incoming inspection for key materials and critical dimensions
  • In-process inspection at molding and assembly checkpoints
  • Final inspection before shipment with release record

Compliance Support

  • Material compliance documentation support
  • Datasheet and technical file support for sourcing teams
  • RFQ response with quality and process confirmation

Certification: ISO13485:2016

Certificate Information

  • Certification body: NQA
  • Certificate standard: ISO 13485:2016
  • Certificate No.: 132729
  • Registered address: Building 4, No.4 Zhanghua Road, Songshan Lake, Dongguan, Guangdong, China

ISO 13485 Certificate

ISO 13485 Certificate