The EU Medical Device Regulation (MDR) was officially passed in May 2017 and manufacturers have until 2020, to be fully compliant with all changes set forth within the new regulation. View this 30 min. webinar to better understand the changes that clinical teams should prepare for now to be successful under the new regulation.
If sponsors want to enroll and retain patients, they must take steps to mediate the information overload & falsehoods that their patients are exposed to and continue to establish trusting relationships with them. Using the correct guidance as a road map, sponsors can work to drive recruitment, enrollment and completion of their trials with more robust data at a lower cost and reach their goals of regulatory approval at a faster rate.
Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise.