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TransMedTech obtains ISO 13485:2016 certification

October 19, 2020

The TransMedTech Institute announces today that it has obtained ISO 13485:2016 certification for its quality management system applicable to its project management activities and to the design and development of medical technologies conducted on its site and in four laboratories of the Sainte-Justine Hospital Research Centre.

The International Organization for Standardization's ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes ( sets out the quality management system requirements for organizations that must provide medical devices and associated services that meet regulatory requirements.

"Obtaining this certification is a significant achievement for the Institute, having mobilized a large number of committed stakeholders. Our quality management system has a structuring effect that reflects our commitment to meeting international needs and standards in the development of innovative medical technologies," said Professor Carl-Éric Aubin, Executive and Scientific Director of the Institute.