The quality and regulatory compliance of diagnostic testing in Europe depend on complex interactions between laboratory workflows, data, and manufacturer-provided components. Under the In Vitro Diagnostic Regulation (IVDR), laboratories—particularly when developing in-house tests (IH-IVDs)—must meet stringent requirements for documentation, risk management, and performance evaluation. At the same time, accessing structured, up-to-date technical and regulatory information from manufacturers remains a key operational challenge.
Platomics has developed PlatoX®, a neutral online platform that facilitates the structured exchange of technical and regulatory information between manufacturers and clinical laboratories. The platform provides tools and infrastructure that support laboratories in preparing IVDR-relevant documentation based on manufacturer-provided data. PlatoX® operates as a neutral digital infrastructure platform that enables the structured exchange of technical and regulatory information between manufacturers and clinical laboratories. Through smart data-processing automation, it transforms manufacturer-provided data into structured, IVDR-ready documentation—streamlining compliance workflows.
Platomics operates PlatoX® as a SaaS platform, offering paid subscriptions to IVD manufacturers and clinical laboratories who need a reliable, structured environment for exchanging technical and regulatory information under IVDR. Platform access gives both sides a shared digital workspace that replaces fragmented, manual communication with streamlined, audit-ready data flows — saving time and reducing compliance risk from the start. On top of core platform access, Platomics offers add-on modules that bring smart automation to the most burdensome compliance workflows — from documentation assembly to risk management preparation. These modules turn what used to take weeks of manual effort into fast, repeatable, error-resistant processes, giving laboratories and manufacturers a scalable path to full IVDR readiness.
Mar 20, 2026
Mar 20, 2026
Mar 20, 2026
Jan 10, 2025