Owkin's ISO certification: ensuring quality AI solutions for digital pathology

Owkin has successfully achieved ISO 13485:2016 certification for the design, development, manufacturing and distribution of its transformational AI IVD diagnostic solutions. The reference standard, ISO 13485 provides stringent regulatory criteria that ensure quality throughout the lifecycle of a medical device; this certification highlights Owkin’s ability to deliver clinically robust solutions for unmet medical needs, developed with the highest quality and safety standards.

With this internationally recognized certification, Owkin streamlines capabilities for achieving CE-IVDR approvals and meeting FDA quality standards for upcoming products and new software version releases. All ISO standards are reviewed every five years to keep them current and relevant for the marketplace. ISO 13485:2016 has a greater emphasis on risk management and is designed to respond to the latest quality management system practices, including changes in technology and regulatory expectations. Furthermore, in 2022, the FDA proposed an amendment to their Quality System Regulation to incorporate ISO 13485 into its quality standards. This step expects to see quality requirements for FDA-regulated devices harmonized with other regulatory authorities around the world, precipitating clinical access in Europe and America to Owkin’s cutting-edge AI-powered diagnostics.

Michael Auffret, Owkin’s SVP of Diagnostic Products and Regulatory states:

With this certification, clinicians and patients can trust that our approach to developing clinically relevant and routine AI diagnostics for digital pathology is robust; our innovative science and technology is backed by thorough quality management, with efficacy and safety at the forefront.

Owkin’s previous ISO certifications include ISO 27001, which centers on Information Security Management. Owkin is also world renowned for its pioneering privacy-enhancing technologies, like federated learning, that protect data rights and privacy while unlocking AI’s capabilities to diagnose, discover and develop better treatments for patients.

Read more about Owkin’s approach to developing responsible, ethical, and safe AI here.