SFL is pleased to provide a new training course entitled “Overview of Medical Device Regulation and Workshop on Software as Medical Device” (17th June, 2019, Basel). The course under the umbrella of the Medtech & Pharma Platform (MPP) will provide an overview on the regulatory system and requirements for medical devices under the EU Medical Devices Regulation (MDR) that is replacing the existing Medical Device Directive (MDD) legislation. Furthermore, the course will include a special focus on Software and Apps under the regime of the MDR. The MDR will come into full effect in spring of 2020.
The course will be given by Karin Schulze (Head of Medical Devices at SFL), with experts from Novartis Miguel Cárdenas (Regulatory Associate Director Medical Devices), Mithun Ratnakumar (Lead Expert Software Development, SaMD projects) and Sonja Lederhilger (Lead Human Factors Engineering) presenting the special focus on SaMDs.
Registration can be done here.