SFL’s Head of Medical Devices to give MDR webinar on interacting with Notified Bodies
SFL’s Head of Medical Devices Karin Schulze, is giving a webinar entitled “Problems with Notified Bodies – And how to solve them” as part of the MDR@noon webinar series organized by Swiss Medtech (15 July 2020; Registration). Karin is a former head of a Notified Body and will provide her expert knowledge on how to interact with your Notified Body to prepare for conformity assessment procedures to prevent problems during the process and how to resolve concerns identified by your Notified Body to facilitate smooth CE-marking of your medical devices.
Karin has extensive experience working on medical devices and in vitro diagnostics (IVDs), and is highly knowledgeable on manufacturing processes according to the various relevant ISO standards, as well as being a qualified auditor. Karin would be happy to discuss your projects and how SFL can support your medical devices and combination products, from strategic advice on development, manufacturing, clinical evaluation and Quality Management Systems (QMS), to CE-marking and post-marketing maintenance. Please contact us to arrange a call with Karin.