Medtech Startup HTG Medical Raises €450K in Round

The company's HTG Urogram device has received EU Medical Device Regulation (MDR) certification. This approval allows HTG Medical to start selling the device across Europe and other global markets immediately.

"Getting a prototype into the ICU with real patients is one thing. Transitioning it into a certified medical device means perfecting countless details hidden beneath the surface—from measurement accuracy and engineering reliability to secure hospital data integration, a robust quality management system, and an airtight development and testing lifecycle,” says Max Klimeš, CTO and co-founder.

“Securing the CE mark is validation that we built this product the right way. Starting with a deep understanding of the real needs of ICU nurses and doctors, all the way to engineering technical documentation that meets the world’s strictest regulatory requirements. We are now ready to deploy the HTG Urogram where it can truly help and start saving time,” says Tobiáš Vybíral, CEO and Co-founder of HTG Medical.

“More than a year of intense regulatory work taught us how to build institutional processes that can withstand any high-stakes international market. ISO 13485 and CE marking under MDR aren't just rubber stamps - they are the core foundations upon which we are building a highly scalable company,” adds Krištof Šaman, COO and Co-founder, who steered the certification sprint.

Founded in 2021 by Tobiáš Vybíral, Max Klimeš, and Krištof Šaman, HTG Medical is a medical technology company based in Prague, Czech Republic.

The company develops innovative healthcare technologies with the goal of improving people's lives and making the world a better place.