Why the Groerilla is at home in the laboratory
Contrary to what you might expect, the “Groerilla’s” favorite territory is a LABORATORY.
While many regulatory experts focus on active medical devices or implants, the Groerilla has found his true home in the laboratory – where diagnostics meets precision and every measurement result counts.
Three worlds, one expertise
The Groerilla understands the three different universes of in vitro diagnostics:
In the clinical laboratory, it’s all about reliable patient results under time pressure, validated methods, and seamless integration into existing workflows. Here, every IVD product must not only be regulatory compliant but also function in daily practice – with different sample materials, changing users, and under quality assurance requirements.
In the academic research laboratory, innovative test methods and new biomarkers are developed. The Groerilla knows the path from research prototype to market-ready product, understands the challenges of transitioning from Research-Use-Only (RUO) to CE-marked IVDs, and knows which validation data is necessary.
In the manufacturer’s test laboratory, quality control, batch release, and performance verification are conducted. Here, the Groerilla is familiar with ISO 13485-compliant processes, stability studies, and analytical performance criteria according to IVDR.
From in-house IVDs to market-ready products
The Groerilla speaks the language of the laboratory: from CLSI evaluation protocols for method validation through analytical performance assessment to clinical validation strategies. He understands the unique regulatory landscape of in-house IVDs and the strategic pathways from initial laboratory-developed tests to commercial products.
Whether you’re starting with an in-house device in a single laboratory or planning technology transfer to multiple sites, scaling up to high-throughput automation, or developing near-patient testing solutions and home-use devices – the Groerilla can implement strategies for every stage of your IVD journey.
Why Groerilla?
Because IVD regulation requires more than standard knowledge: it needs someone who understands how a PCR or an ELISA test is developed, what must be considered when CE-marking a hematology analyzer, why a microscope is not per se an IVD medical device and what Post-Market Surveillance for molecular diagnostic tests must look like.
The Groerilla combines technical understanding with regulatory expertise – and thus brings IVD products safely to market, from the laboratory bench to the patient’s home.
Ready for your IVD project? Contact the Groerilla.