ISO 13485:2016 CMDCAS

Atlas Medic received ISO 13485 CMDCAS initial certification in July 2012.

Atlas Medic has successfully obtain ISO 13485 certificate which is also certified by Canadian Medical Devices Conformity Assessment System (CMDCAS). Canadian regulation requires that class II medical device manufacturer meet the quality management system that meets international ISO 13485 and certifies by a registrar of CMDCAS.

Atlas Medic Quality Management System (QMS) are specifically intended for manufacture and distribution of medical devices. Certificates are issued based on satisfactory audit results verifying that Atlas Medic Quality Management System (QMS) are maintained in compliance with ISO 13485, the Medical Device Directive (MDD), and Canadian Medical Device Regulations. Certification (CMDR) by the CMDCAS Recognized Registrar enables Atlas Medic to maintain valid Canadian Medical Device Licenses (MDL).