bioLytical Laboratories, a developer and manufacturer of rapid infectious disease tests, has successfully earned a certificate for conformance with ISO 13485:2016/MDSAP (Medical Device Single Audit Program).


Image: bioLytical Laboratories earns MDSAP certification. Photo: Courtesy of bioLytical Laboratories Inc.

MDSAP allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that covers ISO 13485:2016 as well as the requirements of participating regulatory jurisdictions which are Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW) and the United States (FDA).  This approach reduces the need for duplicate quality management audits, allowing device manufacturers to better manage resources and ease global market access.

“This achievement is the result of undergoing scrutiny by a recognized auditing organization through multi-phase audits following many months of planning and execution,” said Livleen Veslemes, bioLytical’s CEO. “Achieving MDSAP certification exemplifies our ongoing commitment to maintaining the highest quality assurance standards in the industry and allows us to introduce bioLytical’s revolutionary INSTI technology to support testing initiatives in new markets such as Australia and Brazil.”

bioLytical’s INSTI platform has transformed point-of-care testing approaches in both clinical and non-clinical settings across the world. Marketed since 2006, the INSTI HIV-1/HIV-2 Antibody Test provides instant results from a one minute testing procedure, removing the 20-minute or greater wait time typically associated with competitor point-of-care HIV tests. This ease-of-use, reliability and convenience was adapted for the INSTI HIV Self Test, which is designed for use by individuals in the privacy of their own homes and is currently available for purchase online and in pharmacies in locations across Europe and Africa. Providing a single solution to test for one of the globe’s most concerning co-infection issues, the INSTI Multiplex HIV-1/2 / Syphilis Antibody Test screens for both infections simultaneously on one device in 60 seconds.

Source: Company Press Release