Quality Assurance

We provide our clients with products manufactured in facilities certified to meet the EN ISO 13485 and ISO 9001 requirements, which follow the FDA cGMP guidelines. Additionally our products conform to the following standards as applicable:

  • ANSI/AAMI EC-53
  • ANSI/AAMI HF-18
  • IEC 60601
  • UL
  • DIN 42-802

Our testing capabilities for verification & validation and quality control include:

  • Biocompatibility testing to medical standards such as ISO 10993-5 &
  • ISO10993-10
  • Mechanical: tensile, flex life, impact, connector mate/demate forces & life cycles.
  • Electrical: Continuity, Isolation, Capacitance, Impedance, Dielectric Strength, Triboelectric Noise, Defibrillation
  • Sterilization
  • Environmental
  • Chemical Analysis
  • Custom testing devices and protocols for special applications

 

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