CERTIFICATIONS

GAUMOND MEDICAL GROUP INC. (GMG) is a company that develops, manufactures and distributes high-level medical devices that comply with the most stringent medical regulations and standards. GMG has a quality assurance system to meet the expectations of its customers and complies with Canadian and international regulations. Since 2007, we have implemented a quality assurance system that meets all the requirements of the following standards:

 

International Standards

-ISO 9001:2008  Management system – Requirements

-ISO 13485:2003 - Medical devices – management systems – Requirements for regulatory purposes

 

American Standards

- FDA 21 CFR 820 – Quality System Requirements (USA)

-CMDCAS - Policy on the Evaluation System of the Canadian Medical Devices Conformity

 

European Standards

-93/42/CE - Directive concerning medical devices – Appendix II: Full quality assurance system

-97/23/CE - Directive on Pressure Equipment – Annex III, Module D: Production Quality Assurance

 

Our quality assurance system is audited annually, and allow us to offer you services and products among the most reliable and safe currently available. Our vision is focused on the control and traceability of our products, the satisfaction of our customers and the quality of our services.

ISO 9001 Certificate

ISO 13485 Certificate