Confirm BioSciences Earns ISO 13485:2016 Certification for Its Quality Management System to Handle Medical Devices and Related Services


SAN DIEGO, Sept. 8, 2020 /PRNewswire/ -- Confirm BioSciences, a leading provider of comprehensive screening tools and solutions, today announced that the company was awarded an ISO 13485:2016 certification on August 24, 2020. A third-party audit and certification by UL, a global safety science leader, recognized that Confirm BioSciences meets quality management system requirements to provide medical devices and related services, consistently meeting customer and regulatory requirements according to standards published by the International Organization for Standardization (ISO).

"We've always upheld the highest quality standards in every facet of our business, but this certification validates our best-in-class processes and commitment to customers and partners," said Nikhil Nayak, Chief Operating Officer, Confirm BioSciences. "Quality is a top priority in everything we do, which is how we've been able to grow our Drugs of Abuse testing line so rapidly while adding important new products that support Health & Wellness and COVID-19 testing efforts, including highly accurate antibody and antigen tests and testing controls."

Confirm BioSciences added more than 4,500 new customers in 2020 to date, growing by more than 11%. The company also expanded its partnerships with major national pharmacy chains and other retail outlets in 2020. The robust quality standards Confirm BioSciences already had in place prior to the ISO 13485:2016 certification are key factors in its ability to rapidly gain market share for its core business while scaling up to provide testing support during the pandemic.

UL, which conducted the third-party audit of Confirm BioSciences and issued the ISO 13485:2016 certification, is authorized to certify that companies meet the standards published by ISO, an independent, non-governmental global organization with 165 members representing national standards bodies worldwide. ISO experts develop standards to support innovation and solve global challenges. According to ISO, the ISO 13485:2016 standard was reviewed in 2020 and remains the current standard.

"We're grateful to our Confirm BioSciences team members who worked so hard to successfully complete this audit and secure ISO 13485:2016 certification," said Albert Berger, Chief Executive Officer, Confirm BioSciences. "Our quality management system has an impact on virtually all company operations, so we're thankful for everyone's efforts and proud of this achievement, which is tangible proof of our commitment to quality."

About Confirm BioSciences

Confirm BioSciences is a leading provider of high-quality, comprehensive screening tools and solutions across the full spectrum of health and wellness. With core competencies in testing drugs of abuse and broader health metrics, Confirm is dedicated to providing its customers with meaningful, actionable information. The company's product portfolio ranges from instant and lab-based testing solutions for drugs of abuse, including HairConfirm® and DrugConfirm®, to HealthConfirm®, a line of testing solutions for health and wellness, with results delivered in insightful user-friendly reports. As an industry authority, Confirm educates and empowers its customers, and supports initiatives that create drug-free and healthy homes, workplaces and communities. The company is headquartered in San Diego, California. For additional information, visit

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