ISO 13485:2003 - Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes.
CMDCAS - Canadian Medical Devices Conformity Assessment System, Quality Systems Regulations.
FDA-QSR - Food and Drug Administration, Quality Systems Regulations.
CE Certificate - Annex II of Medical Device Directives (MDD), 93/42/EEC.
CSA Mark - Conforms to CSA International Standards for selling devices in the U.S., Canada or International markets.