Michael Kühler is a seasoned leader in the medical device and combination product industry, with over 25 years of engineering and regulatory experience. He has held senior roles at Bayer AG and is currently a Regulatory Affairs Senior Expert for Medical Devices, focusing on strategic and operational topics in global regulatory affairs for medical devices and drug-device combination products, including Notified Body Opinions. Michael also leads an EFPIA working group on “Consistency of NBOp Assessments.” Previously, he directed R&D and Regulatory Affairs at Hemoteq AG and managed R&D teams at B.Braun Melsungen AG, contributing to the development of medical devices and combination products. He holds a PhD in Biomedical Engineering from the Technical University of Berlin.