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Lecture – Ian Meredith, MD, Boston Scientific

Ian Meredith, MD Exec VP and Global Chief Medical Officer, Boston Scientific Learning Objectives Understand the elements that contribute to technology adoption Learn about the importance of the unmet need, ease of use, and empowering patients Learn the importance of clinical evidence and digital technology Understand the importance of economics in technology adoption

Lecture – Robert Byrne, MD, Heart Centre, Germany

Robert Byrne, MD, BCh, PhD German Heart Centre, Munich, Germany Learning Objectives Understand the European regulatory requirement Learn the European regulatory processes Understand the new legislation MDR 2017 Learn the medical device regulation 2017 Understand the risk-based classification Learn about the MDR 2017/745 clinical evaluation Learn about the clinical evaluation consultation procedure