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Tm Biosciences Receives US, Canadian Standards Certifications for Genetic Tests

NEW YORK, Nov. 3 (GenomeWeb News) - Tm Bioscience of Toronto has received a certification that its processes meet standards for both US and Canadian medical device standards, the company said today.

 

The company's quality management system has been certified to both the ISO 13485:1996 standard and the requirements of the Canadian Medical Devices Conformity Assessment System, the company said. The certificate covers processes for development, manufacture, and distribution of genetic tests for mutations in the areas of hematology, cystic fibrosis, toxicology, and other areas, as well as analyte specific reagents, in vitro diagnostic medical devices, and software used to test for genetic mutations, according to Tm.

 

Tm launched its P450 2D6 test in June.

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