ISO 13485:2016 is the internationally recognised quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. We are proud to announce we have been recertified by BSI after a successful audit of our portable diagnostics. It enables AgPlus Diagnostics to continue to develop technology in compliance with the highest standards for safety and product performance, and to make its portable diagnostic products available for the first patient treatment once approved.

Please contact us if you require further information about our quality standards.