Global Regulatory Intelligence: Evaluating the Developments to the EU MDR • Generis

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.”

Questions discussed:

• As a VP of Global Regulatory Affairs, how important is it to be aware of and adhere to the new EU MDR?
• In your opinion, what will be the biggest challenge surrounding the EU MDR impact?
• How has Terumo BCT adapted to meet the EU MDR?
• How has your role in the global regulatory landscape evolved?
• What do you look forward to most in the regulatory field in the next five years?
• What advice do you have for current regulatory leaders?

Click through to read the full interview with Michael Santalucia on “Global Regulatory Intelligence: Evaluating Developments to the EU MDR”. 

Michael will be joining us at the American Medical Device Summit in October, where he will speak on the same topic.