The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.
NAMSA, a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, and Terumo Aortic, a developer of aorta-focused medical devices, announced that they have entered into a strategic outsourcing partnership to assist with the acceleration and commercialization of Terumo Aortic’s innovative aortic disease products.
The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.