Navigating the IVDR: How Aiosyn prioritized compliance from day one
Editor2025-05-30T07:49:09+00:00Key takeaways IVDR represents a significant overhaul of regulations requiring more rigorous oversight, clinical validation assessed by a Notified Body, and stricter post-market surveillance (PMS). Aiosyn’s AI-powered solution for mitotic figure counting was built from the ground up to comply with IVDR’s highest regulatory standards rather than transitioning from the superseded IVDD. Aiosyn avoided the transition [...]











