Kalms Consulting cordially invites you to the free webinar in German language in cooperation with Taylor Wessing Germany:
“Software as a Medical Device under the IVDR” on 20.04.21 from 10-12:30 with contributions on the legal requirements, regulatory requirements, and a keynote presentation on UDI by Guido Hammer (GS1 Germany GmbH).
We look forward to your registration at: TaylorWessing.com – Register Now
The European Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) places high demands on manufacturers of medical software. In this context, the software can be considered stand-alone or as part of a diagnostic multi-component system. The requirements for qualification, classification, validation, as well as the requirements for safety and life cycle will be highlighted from a practical perspective.Published on: April 12, 2021