SFL invited to give keynote speech on CE certification of medical devices
SFL’s Head of Regulatory Affairs and Medical Devices, Karin Schulze, will speak at two upcoming seminars organized by Fraunhofer Portugal in the context of MDevNet, the Portuguese National Network for Knowledge Transfer on Medical Devices. During the two seminars, taking place on the 11thand 12thof July in Porto and Aveiro, respectively, Karin will present the requirements and processes to obtain CE certification under the Medical Devices Regulation (MDR), as well as the main changes compared to the Medical Devices Directive (MDD). She will also explain the major differences between EU and US requirements for medical devices.
SFL’s Regulatory Affairs department is supporting clients in ensuring business continuity during the transition period to the MDR. Please contact us to arrange a meeting with Karin.