Our team possesses extensive experience collaborating with MHRA, US FDA, and EU agencies, offering comprehensive support throughout the entire product development process, from premarket approval to post-market surveillance and international marketing. We provide a platform to aid device manufacturers in managing the resource challenges associated with EU MDR and IVDR. This advanced platform enables efficient handling of post-market surveillance documentation, such as Clinical Evaluation Plans and Reports, ensuring compliance for your equipment and IVDs marketed or intended to be launched in the EU. Our suite of services, including EU MDR-related support, enables you to focus on your core responsibilities. With our assistance, your regulatory and quality teams will find it easier to bring your devices to market and maintain their presence there.
