Quality / Regulatory

All medical devices manufactured by Argon Medical Devices, Inc. have been designed, developed and manufactured using standards specified by ISO 13485:2003 and the U.S. Food and Drug Administration.

For Quality/Regulatory Issues or Customer Quality Complaints contact us at Quality.Regulatory@argonmedical.com

View our ISO 13485 Certificates:

Wheeling, IL 13485 Certificate
Athens, TX 13485 Certificate
Singapore 13485 CMDCAS Certificate
Singapore 13485 UKAS Certificate
Singapore EMC 14001 Certificate
Korea GMP Certificate

View our CE/DE Certificates:

Quality System Certificate DGM-377 PBN Medicals DS/EN ISO 9001:2008 And DS/EN ISO 13485:2003 
Certificate of Registration Quality Management System FM 565435- ISO 13485: 2003
People’s Republic of China SFDA(1) 20063660809 PBN Medicals Denmark A/S
EC Design Examination Certificate: Certificate CE 608299 WORKERTM  Guidewires
EC Design Examination Certificate: Certificate CE 608298 AtrieveTM Vascular Snare Kit
EC Certificate Full Quality Assurance System: CE 565719 Directive 93/42/EEC
EC Certificate DGM-375 PBN Medicals Annex II, section 3.2 – Full quality assurance system
Health Canada Drainage Catheters – Polyurethane PBN Medical Denmark A/S
L-Cath PICCTM Catheter DE certificate
Athens, TX Full Quality Assurance Certificate
Athens, TX Production Quality Certificate
UltraStream Chronic Dialysis Catheter Kits DE Certificate
Singapore Full Quality Assurance Certificate
Careflow™ Arterial and Central Venous Catheters DE Certificate
Endomyocardial Biopsy Forceps (Jawz™) DE Certificate
Exacta™ Percutaneous Sheath Introducer Kits DE Certificate
Guidewires DE Certificate
First PICC™ Catheter DE Certificate
H-BAC coated Pulmonary Artery Catheter DE Certificate
Hydrocath™ Assure Central Venous Catheter Kits DE Certificate
Secalon™ Seldy/Secalon™ T Central Venous Catheters DE Certificate