Medical Device

Our team has extensive experience working with the below MHRA, US FDA and EU agencies and can assist you through the entire process of product development, premarket approval, post-market surveillance, and international marketing. We provides a forum to assist device manufacturers in addressing the resource burden associated with the EU MDR and IVDR. This cutting-edge platform allows our team to efficiently manage your post-marketing surveillance documentation, such as Clinical Evaluation Plans and Reports, in order to maintain conformity for the Equipment and IVDs that you currently market and intend to launch in the EU. Our range of services, which includes EU MDR-related assistance, allows you to concentrate on your primary responsibilities. With our assistance, your regulatory and quality teams will have an easier time bringing your devices to market and keeping them there.