CertHub raises €6.2M to tackle medtech’s compliance bottleneck

Munich-based startup CertHub has secured €6.2 million in funding to revolutionize compliance in the medtech industry. This investment addresses the significant regulatory burdens faced by European medical device manufacturers, aiming to streamline the approval process and accelerate innovation in the sector. The funding round signals growing investor interest in AI-driven solutions to solve industry specific problems. CertHub's platform uses AI to automate critical regulatory processes, including technical documentation, quality management, and audit preparation. The company claims its technology can reduce documentation time and costs by up to 60%, potentially saving manufacturers €2.4 million per certification cycle. The investment round was led by Cusp Capital, with participation from D11Z, Calm/Storm, UnternehmerTUM, and several business angels. The impact of CertHub's technology extends to both manufacturers and Notified Bodies, promising faster market approvals and improved documentation quality. By easing regulatory bottlenecks, CertHub aims to allow life-changing medical technologies to reach patients sooner. With this funding, CertHub plans to expand across Europe, integrate with more Notified Bodies, and develop tools for the US and Brazilian markets. CertHub's long-term vision is to establish a shared compliance infrastructure, creating a valuable dataset for predictive compliance and data-driven product approvals. This initiative could significantly transform how medical devices are certified, leading to a more efficient and innovative healthcare ecosystem within Europe and beyond.