Aignostics achieves ISO 13485 certification to support clinical research and diagnostics development
October 20, 2023
Aignostics, a global leader in AI-powered pathology, today underscores its commitment to regulatory and operational excellence by announcing its successful ISO 13485:2016 certification. This certification confirms Aignostics' adherence to the stringent regulatory criteria for the design, development, manufacturing, and distribution of software as a medical device.
Complementing the existing ISO 27001 certification for its Information Security Management System (ISMS), the ISO 13485 standard ensures a comprehensive quality management system (QMS) with a strong emphasis on risk management. Aignostics has already established its QMS in 2020 and has now successfully certified it to underline its position as one of the very few players in this space who fulfill the highest standards for information security and product quality.
Viktor Matyas, CEO of Aignostics, commented, "The ISO 13485:2016 certification is a testament to our goal to be leaders in compliance, quality and information security, all of which we consider key pillars of success to be a trusted research and development partner to biopharma. While this has always been true, it was time to get certified to support our clinical research and diagnostics development efforts. We are proud of our team to have achieved this milestone."
Aignostics is a spin-off from Charité - Universitätsmedizin Berlin, and a global leader in AI-powered precision medicine. Started in 2018, Aignostics’ has a team of ca. 100 employees in Germany and the US, and is primarily active in discovery, translational, and clinical research with globally leading pharma and biotech clients.