Is your company prepared for the new EU MDR? Michael Santalucia, Vice President of Global Regulatory Affairs for Terumo BCT, is responsible for managing the global regulatory affairs function regarding the development and execution of product submission strategies for the company’s medical devices, regulatory compliance requirements, and industry advocacy. As medical device companies face large regulatory challenges to comply with the new European Union Medical Device Regulation (EU MDR), we sat down with Michael Santalucia to learn how Regulatory Affairs organizations are evolving along with global regulations, what Terumo BCT has been doing to comply with EU MDR, and how members of the medical device industry can stay informed. “The EU MDR is arguably the most important legislation to affect our industry in the last two decades. Because of the impact this will have for any firm with CE marked devices, it is essential to have someone in the organization that can provide the company with advice and guidance to the requirements that have been established and those that are yet to evolve.”