SFL’s Head of Regulatory Affairs & Medical Devices, Karin Schulze, will participate in the MDR Readiness Day organized by Swiss Medtech, that will take place in Solothurn on 18 October 2018.

The event will provide practical guidance for those directly affected by the MDR implementation, including those in the regulatory affairs field, QMS managers, manufacturers, suppliers, importers and distributors. Topics covered include the timelines relating to both the implementation of the Medical Devices Regulation (MDR), as well as steps within the certification procedure, including the preparation of clinical evidence, technical documentation and labeling under the MDR.

Karin and the SFL’s Regulatory Affairs department supports clients to achieve a smooth transition of existing medical devices, in vitro diagnostics and combination products covered under the old MDD to the incoming MDR and IVDR, by ensuring these devices fulfil the newer and more rigorous certification requirements.

In addition, Karin is Chair of the Medtech & Pharma Platform’s (MPP) working group on the implementation of the new MDR and how it affects the rapidly developing area of combined products. Visit us at the MPP annual event in Basel on 16-17 October 2018.

If you wish to arrange a meeting with Karin, please get in touch with us.