Platomics

Platomics GmbH, a Vienna-based HealthTech and Regulatory Technology (RegTech) company, was established in 2017. The company's genesis is directly linked to the extensive experience of its founders in the diagnostics industry. Albert Missbichler, with a background in molecular biology and prior roles at the Austrian Agency for Health and Food Safety (AGES) and as a lead auditor for medical devices, and Ernst-Arno Lemke, with his experience in quality and risk management for IVD products, identified a critical bottleneck in the industry. Their direct exposure to the burdensome, manual, and document-heavy processes required for regulatory compliance under the new In Vitro Diagnostic Regulation (IVDR) spurred the creation of Platomics.

The company targets a significant challenge within the European Union's healthcare sector: the stringent IVDR (EU) 2017/746, which mandates that all in-vitro diagnostic tests, including those developed in-house by laboratories, undergo a rigorous approval process. Platomics serves in-vitro diagnostic manufacturers and clinical laboratories, which face substantial time and resource commitments to meet these compliance requirements. The firm's business model is centered around its proprietary SaaS platform, PlatoX®, designed to digitize and automate these complex regulatory workflows. By shifting the paradigm from manual document management to intelligent data handling, Platomics aims to drastically reduce the administrative burden and associated costs for its clients.

PlatoX® is a comprehensive digital platform that provides a suite of tools for managing the entire lifecycle of IVD regulatory compliance. For manufacturers, it facilitates the creation and maintenance of technical documentation required for CE marking under IVDR. For clinical laboratories developing their own tests, the platform offers dedicated modules to manage performance evaluations and post-market surveillance, ensuring adherence to IVDR standards. A key feature is its marketplace functionality, which connects IVD manufacturers with laboratories. This allows manufacturers to efficiently distribute their technical documentation and performance data, while laboratories can access and utilize this information to streamline the validation of their own diagnostic tests. This collaborative ecosystem is designed to accelerate the time-to-market for new diagnostic solutions and ensure patient access to necessary tests.

Keywords: Regulatory Technology, RegTech, HealthTech, In Vitro Diagnostics, IVDR, compliance automation, medical device regulation, SaaS, clinical laboratories, diagnostic tests