GUELPH, CANADA, July 19, 2021 – Precision Biomonitoring has received an ISO 13485 certificate issued by BSI for the design, development, and manufacturing of in-vitro diagnostic kits for the detection of viruses and infectious diseases. The Guelph-based company has supplied industries across Canada with rapid-testing kits since the start of the COVID-19 pandemic.
This ISO 13485 certification is an important milestone for Precision Biomonitoring. The certificate shows that the company meets the most current quality standard specific to designing, developing, and manufacturing medical devices that consistently meet customer and regulatory requirements.
“This international certification further validates our commitment to excellence, safety and delivering best-in-class molecular virus and disease detection through our high-quality medical products. It also advances our vision of providing innovative tools needed to protect public health and maintain key economic drivers in Canada through testing,” said Stephanie Gallone, Director of Regulatory, Quality and Clinical Affairs, Precision Biomonitoring. “While vaccines are showing promise in their ability to slow the spread of COVID-19, testing will continue to play a critical role in ensuring the safety of Canadian workplaces and identifying trends as the virus evolves. As the pandemic enters a new phase, the ISO 13485 certification provides Precision’s customers with an objective basis for their trust and confidence in the quality of our testing technology.”
Precision Biomonitoring is one of the first companies to provide rapid, mobile diagnostic and detection kits in Canada. It has grown from a small company specializing in environmental DNA pivoting to becoming an innovator in human health diagnostics. They are now a trusted partner to governments and industries, providing innovative technology to support companies with COVID-19 testing for employees. With a growing pipeline of testing technology along with deep roots and understanding of the testing landscape, the company is positioned to play a key role as Canada continues its response to COVID-19.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. Many countries recognize, or even require, this certification in order to access their market. ISO 13485 is recognized by Health Canada.
About Precision Biomonitoring
Founded in 2016, Precision Biomonitoring provides industry-leading expertise in molecular direction of organisms. Their very own TripleLock™ technology aims to deliver rapid, on-site environmental, food, animal and human diagnostic testing solutions. Customers are any organizations that need onsite surveillance and rapid identification of any organism in any environment. The Precision Biomonitoring team is at the forefront of technological innovations in the genomics industry. Our vision is a world where we can identify any organism on the spot, in an instant, anywhere on the planet.