CE plus is a division of regenold GmbH, specializing in regulatory strategy and implementation for medical devices and in vitro diagnostics. The core competency of CE plus lies in CE marking for European markets, customized quality management systems, and any other activities that help clients realize market success.
CE plus’ relationship with regulanet® allows them to access resources and manage complex international projects.
CE plus uses interdisciplinary teams to develop project-specific solutions tailored to clients’ needs, helping them maximize market asset value.
For more information, visit us at: www.ceplus.eu
Given the popularity of medical apps and software being used within the framework of Medical Devices and IVDs, their importance is rising annually. Along with this one may find the challenge of finding the border between software intended for wellbeing or fitness purposes and software designed for medical purposes according to MDR/IVDR.
We support you in qualifying and classifying your software by considering guidelines such as the “MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”. Regardless of whether you use agile, V-model or waterfall methods we will ensure your Medical Device Software complies with the requirements outlined in the Harmonised Standards IEC 62304 and the Health Software Validation Standard IEC 82304.
Oliver Hilgers looks back on 10+ years of experience in the field of Medical Device Software (MDSW). Next to his dedicated work for our clients to achieve CE-mark Oliver trains MDSW requirements at the TÜV Rheinland Academy as well as working as Mentor for EIT Health and other Innovation Hubs and Accelerators.
Head of CE plus: Active Medical Devices