This training aims at providing a comprehensive overview of the regulatory system and requirements for medical devices in Europe with particular focus on combination products.
Agenda
Highlight of the key changes in the MDR 2017/745 Update latest changes
MDR Implementation for Medical Devices – Industry Perspective
MDR Implementation for Article 117 impacted combination products – Industry Perspective
Presenters
Karin Schulze
Head of Medical Devices, SFL
Stephan Affolter
Regulatory and Quality Intelligence Manager, Ypsomed
Juan Martin Carriquiry
EU MDR Expert, Device Development & Commercialization, Novartis