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Quality/Regulatory

    1. We produce quality products throughout every single step of manufacturing process.

    2. We maintain a Quality Management System with compliance to applicable regulatory requirements and applicable International Standards. ISO 13485 and CE certifications are available upon request (ISO/CE cert shown below).

    3. We work with our partners/customers to collect post-market feedback to ensure that the products being sold perform the function for which they were produced.

  • Q1N141190279003 CE Cert 1
  • Q1N141190279003 CE Cert 2
  • Q1N141190279003 ISO 13485