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Regulatory & Quality

Quality is our priority! We are making healthcare better by providing timely and accurate medical devices and services which meet regulatory requirements through an effective quality system and a safe work environment.

All medical devices manufactured by Argon Medical Devices, Inc. have been designed, developed and manufactured using standards specified by ISO 13485:2016 and the U.S. Food and Drug Administration.

If you’d like to share information with us about your product experience, please

If you have questions on regulatory documentation, global registrations, quality agreements, certifications or other compliance questions, please let us know at

  • Athens TX Full Quality Assurance Certificate
  • Athens TX Production Quality Certificate
  • Atrieve Vascular Snare Kit CE Certificate
  • First PICC Catheter DE Certificate
  • Guidewires DE Certificate
  • Jawz Endomyocardial Biopsy Forceps DE Certificate
  • L-Cath Peripherally Inserted Central Catheters DE Certificate
  • OptionELITE Vena Cava Filter System CE Certificate
  • UltraStream Chronic Dialysis Catheter Kit CE Certificate
  • Worker Guidewires CE Certificate
  • Athens TX Korean cGMP Certificate
  • Korean Certificate of GMP
  • Athens TX 13485 Certificate
  • Henrietta NY 13485 Certificate
  • Wheeling IL 13485 Certificate
  • Japanese Registration Certificate
  • MDSAP 694618