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Overview
BioSistemika is a Slovenian technology company founded in 2012 and based in Ljubljana. It develops laboratory software and digital tools for life science workflows. The products are used by research and diagnostic laboratories.
News
Is Your Laboratory Software Ready for Regulated Markets?
Reading Time: 6 minutes For years, hardware drove innovation in laboratory instrumentation. Faster pumps, more precise liquid handling, higher-resolution detection, better automation, higher throughput: these were the specs that decided how labs judged ne
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Lab Digitalization is Like Moving to a New Home: Best Practices from the Front Lines
Reading Time: 4 minutes Recently, I was visiting a prospective client and asked them a simple question: "Why are you looking for a new digital solution?" Their answer was incredibly literal: they told me the floor of their laboratory was practically colla
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Report
Cyber Resilience Act: Answers to the Questions from Software Vendors in Life Sciences (Part 2)
Reading Time: 6 minutes Following the first part of our Ask Our Experts campaign on the Cyber Resilience Act (CRA), we are continuing with another set of practical questions submitted by software vendors and companies operating in regulated environments.
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Cyber Resilience Act: Answers to the Questions from Software Vendors in Life Sciences (Part 1)
Reading Time: 7 minutes The Cyber Resilience Act (CRA) is introducing mandatory cybersecurity requirements for software and connected products placed on the EU market. As part of our Ask Our Experts campaign, we invited companies to submit their biggest c
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What the Proposed MDR/IVDR Simplification Means for Medical Device and IVD Manufacturers
Reading Time: 5 minutes On December 16, 2025, the European Commission proposed MDR/IVDR simplification, a legislative package to simplify the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Driven by the need to
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