BugSense revolutionizes Urinary Tract Infections (UTI) diagnostics with a paper-based point-of-care device that detects bacterial infections and antibiotic resistances. Starting from TUM academic research, the team partnered with CertHub's Fast Track to Certification program to achieve faster time-to-market and a clear road to success.
Founded by molecular biotechnologist Sarah Wali at TU Munich, BugSense develops a paper-based diagnostic platform delivering laboratory-quality UTI diagnosis at the point of care. Backed by Bavarian Ministry of Economic Affairs & Heinz-Nixdorf Chair of TU Munich, they address the €2.8 billion global UTI diagnostics market where 400 million patients face delayed treatment due to lengthy laboratory procedures. As a lean startup in the fast-moving diagnostics market, they needed to minimize regulatory costs while maximizing speed to market.
Within just two weeks, BugSense completed an intensive Onboarding and Regulatory DeepDive Session with CertHub’s IVD Expert Dr. Sebastian Grömminger and regulatory specialist Tayis Arslan. Using insights from this session, CertHub’s AI Certification Assistant configured the platform specifically for BugSense’s IVD device, defining the optimal regulatory pathway within days. Over the following weeks, the DxTech framework transformed research data into regulatory-compliant documentation, while the AI Auto-Extractor converted clinical studies into structured product files. At the same time, CertHub’s Process framework enabled the creation of ISO 13485–compliant SOPs in only four weeks—cutting the typical 16-week timeline by 75%. Overall, BugSense achieved certification readiness 75% faster, saving up to €205,000 in regulatory costs, enabling an estimated €1.2 million in first-year revenue, and realizing a 2,667% ROI within the first year.
Founded by molecular biotechnologist Sarah Wali at TU Munich, BugSense develops a paper-based diagnostic platform delivering laboratory-quality UTI diagnosis at the point of care. Backed by Bavarian Ministry of Economic Affairs & Heinz-Nixdorf Chair of TU Munich, they address the €2.8 billion global UTI diagnostics market where 400 million patients face delayed treatment due to lengthy laboratory procedures. As a lean startup in the fast-moving diagnostics market, they needed to minimize regulatory costs while maximizing speed to market.
Within just two weeks, BugSense completed an intensive Onboarding and Regulatory DeepDive Session with CertHub’s IVD Expert Dr. Sebastian Grömminger and regulatory specialist Tayis Arslan. Using insights from this session, CertHub’s AI Certification Assistant configured the platform specifically for BugSense’s IVD device, defining the optimal regulatory pathway within days. Over the following weeks, the DxTech framework transformed research data into regulatory-compliant documentation, while the AI Auto-Extractor converted clinical studies into structured product files. At the same time, CertHub’s Process framework enabled the creation of ISO 13485–compliant SOPs in only four weeks—cutting the typical 16-week timeline by 75%. Overall, BugSense achieved certification readiness 75% faster, saving up to €205,000 in regulatory costs, enabling an estimated €1.2 million in first-year revenue, and realizing a 2,667% ROI within the first year.
CEO, BugSense
"CertHub eliminated regulatory uncertainty paralyzing our go-to-market strategy. We can go from research to market so much faster while always having a clear plan and road to success."
We tailor our solution to our customers not the other way around Typical software requires companies to adapt to the structure of the software, we tailor our software to the specific needs of the medical devices of our customers, if you have a hardware device you get a completely different configured CertHub compared to SaMD.
€100,000+ Cost Savings through AI-driven certification support. 73-82% reduction in regulatory costs enables resource allocation to R&D and market development instead of compliance overhead.
Documentation Progress in 4 Weeks, not 6–9 months. Speed is completely dependent on the capacities of the startup teams themselves, we support when support is required. Market entry creates sustainable competitive advantages in rapidly evolving diagnostic markets. You start earlier and with a clear path.
Our solution growths with our teams, you can use us from 3 to 5000 employees, startup only solutions you need to change again soon after your first certification.
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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