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Software as medical product, MDR/ IVDR Workshop at CeNTech

from l. to r. Dr. C. Spring (project partner Bioanalytik Münster), M. Engler (expert, Benkana Interfaces), Dr. H. Winter (CeNTech GmbH), I. Aschhoff (project partner Gesundheitswirtschaft Münsterland)

December 14, 2022

Software as well as medical apps are affected by the new EU Medical Device Regulation (MDR). As these requirements are rather complicated, the project MDR-support@NRW ( addressed these topics in a workshop on December 13 at CeNTech. Michael Engler from Benkana Interfaces GmbH & Co. KG gave an overview about SOFTWARE AS MEDICAL PRODUCT and furthermore in-depth information about classification, software requirements, quality and risk management related to software.