Medical Devices

The EU Medical Device Regulation (MDR) requires a more stringent characterization of products in the Medical Device field. The MDR is madatory for all new products and existing products have to comply by May 26th 2020. Tentamus Pharma Labs are equipped to support you in fulfilling MDR requirements. Biological endpoints (e.g. haemocompatibility, cytotoxicity, genotoxicity, irritation, etc…) as well as chemical characterization (e.g. extractable & leachable studies, etc…) is available at our laboratories. In addition to these analytical tests, medical testing for stents & stent graft, vascular graft, catheters, heart valves and other devices is available at Tentamus Pharma Labs. Contact us and arrange a meeting with our experts to learn more about our capabilities.