Manufacturing

MedMira manufactures, assembles, and packages its rapid diagnostics at its facilities in Canada. 

We have implemented and maintain a formal Quality Management System in order to meet our regulatory requirements for product approvals and to provide the highest quality product to our customers.  This system is ISO 9001:2008 and ISO 13485:2003 certified and compliant with the United States Food and Drug Administration’s Quality System Regulations (21 CFR 820), Health Canada Medical Device Regulations (SOR/98-282), and the European Union Directive on In Vitro Diagnostic Medical Devices.  Certification and compliance to these requirements attests to MedMira’s ability to maintain the highest standard of quality in medical device manufacturing, product development, and corporate conduct.