At Atrion, providing our customers with the highest quality medical devices is the standard.
Atrion's quality system is focused on satisfying our customers’ needs, 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:
- Quality System Regulation, US FDA 21 CFR Part 820
- Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes: ISO 13485:2016
- European Medical Device Directive (MDD), 2007/47/EC and 93/42/EEC
- Canadian: SOR/98-282 Medical Devices Regulations
- Brazilian Medical Device Regulations RDC ANVISA 16/2013
- Australian TGA 1989
- Australian TGA (Medical Devices) Regulations 2002
- Japanese Pharmaceutical & Medical Device Act (PMD Act) regulation
- Japanese Medical Device Quality Management System Ministerial Ordinance No. 169
Atrion has been a registered establishment with the FDA since 1976 and certified to the ISO requirements since 1996.
Atrion's Lean Manufacturing programs continuously move products to higher levels of quality and reliability.