CERTIFICATES
Quality System Certifications
ISO 13485:2003 - Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes.
CAN/CAS - Canadian Medical Devices Conformity Assessment System, Quality Systems Regulations.
Product Clearances & Certifications
FDA clearance
CE Certification
CSA Mark - Conforms to CSA International Standards for selling devices in the U.S., Canada or International markets.