Nijmegen – Aiosyn, a medical software company that develops AI-powered pathology software, has achieved ISO:13485 certification, after successfully auditing its Quality Management System (QMS) by The British Standards Institution (BSI). Achieving this certification demonstrates Aiosyn’s commitment to producing high-quality AI-powered medical devices for pathology.
ISO 13485:2016 is a globally recognized standard for designing and manufacturing medical devices. The standard includes QMS requirements for design and development, document control, management, analysis, and continuous improvement. The certification demonstrates an organization’s ability to provide medical devices and related services that consistently meet the highest customer and applicable regulatory requirements.
Wouter Bulten, CIO of Aiosyn
“Achieving this ISO certification is a critical milestone for Aiosyn and the team. It demonstrates our progress in a fast-changing field of IVDR, AI, and digital pathology.”
Aiosyn aims to leverage this certification as an enabler of its regulatory strategy and product roadmap.
Aiosyn is a Dutch medical software company that develops AI-powered pathology solutions that will be integrated into standard pathology workflows. The Aiosyn teams have been built upon 20+ years of research experience in pathology and are rooted in the pathology practice.