The Groerilla’s digital domain
When diagnostics meets software, complexity multiplies. The Groerilla has been navigating this intersection since 2012 – turning bioinformatics algorithms into compliant IVD software and defending them before notified bodies.
From bioinformatics to regulatory approval
Back in 2012-2017, the Groerilla successfully brought a bioinformatics software through the full regulatory lifecycle: from initial development to CE-marking as IVD-MDSW under Directive 98/79/EC Annex II List B, through continuous development and ultimately defending its classification and technical documentation before the notified body.
This wasn’t just paperwork – it was about translating complex algorithms into validated, verifiable medical devices that deliver reliable diagnostic results.
Protecting Laboratory Information Systems
Since 2017, with the IVDR on the horizon, the Groerilla has been the guardian of multiple Laboratory Information Systems (LIS). The challenge? These platforms serve both general laboratory management purposes and specific medical decision-making functions.
The Groerilla’s solution: strategic segregation. By clearly delineating MDSW modules from platform software, he has preserved the flexibility of general-purpose laboratory systems while ensuring that modules with medical intended purpose meet full IVDR requirements. This segregation strategy has saved manufacturers from unnecessarily placing entire LIS platforms under medical device regulation.
Clinical Decision Support Systems
Beyond laboratory software, the Groerilla has worked with renowned Clinical Decision Support Systems (CDSS), understanding the nuanced boundary between information tools and medical devices. He knows when clinical algorithms trigger IVDR classification and when they remain general-purpose software – and more importantly, how to document and justify these determinations.
The MDSW expertise you need
Whether you’re developing:
- Bioinformatics software for next-generation sequencing analysis
- Laboratory Information Systems with integrated result interpretation
- Clinical Decision Support algorithms
- AI/ML-based diagnostic tools
- Interface software between analyzers and clinical systems
The Groerilla understands both the technical architecture and the regulatory framework. He knows how to structure your software to meet IVDR requirements while maintaining practical functionality, how to conduct software validation according to IEC 62304, and how to prepare technical documentation that withstands notified body scrutiny.
Software meeting medical devices? Let’s talk the Groerilla’s language.