At Atrion, providing our customers with the highest quality medical devices is the standard.
Atrion's quality system is focused on satisfying critical specifications, continuously improving all products and complying with regulatory requirements. Regulatory services include 510(k) and technical file preparation and assistance with CE Marking.
Our quality system is in compliance with the FDA's Quality System Regulation (QSR) for Medical Devices, 21 CFR - Part 820 and has been certified to meet the requirements of ISO 13485:2003, CMDCAS ISO 13485:2003 for Health Canada. Atrion has been a registered establishment with the FDA since 1976 and certified to the ISO requirements since 1996.