Pinpointing which components need stability testing, when to test, and how to comply with global regulations can feel overwhelming. Internal capabilities are often limited, and the time and cost required to build testing infrastructure is high. Meanwhile, delayed or failed tests can trigger costly redesigns or missed launch dates. Eurofins Medical Device Services network of laboratories brings clarity, precision, and confidence. Our global network provides extensive material and product stability testing services to confirm performance, packaging compatibility, and product safety over time.

We conduct both accelerated and real-time stability studies, evaluating your products under controlled conditions of temperature, humidity, light, and more. Our testing methods meet international regulatory standards including ICH Q series, FDA guidance, and EU MDR requirements.

Our laboratories simulate environmental factors such as pH, agitation, and gravity, and assess chemical, physical, and microbiological stability such as degradation, sterility, and therapeutic performance over time. Our sampling and testing strategies are tailored to your device’s components and configurations; biocompatibility assessments as part of long-term product changes; and shelf-life verification to support product claims and expiry dates. Once your medical device is approved, we support ongoing stability testing to monitor any emerging issues over time.