CE plus: Digital Health & Innovation

Digital Health & Innovation Team

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

Digital health and innovation involves using technology to improve healthcare delivery, patient outcomes, and the overall healthcare system. This can include DiGAs, DiPAs, telemedicine, health apps, wearables, and remote patient monitoring.

Digital Health faces challenges in regulation due to the rapid pace of technological advancements, balancing patient safety with innovation, determining regulatory bodies, privacy and security concerns, equitable access to technologies, standardization, and the need for ongoing evaluation and updating of regulations. Effective regulation is critical to ensure safe and effective use of these technologies to improve healthcare outcomes.

Oliver Hilgers is a Regulatory Expert and Head of Digital Health & Innovation with over 20 years of experience in software and CE-marking digital products. He is a member of multiple European regulatory committees, constantly keeping up with the latest trends and software practices. With his extensive knowledge, he helps clients to navigate the complex regulations related to Medical Device Software, DiGA & DiPA, Digital Biomarkers, and AI-driven software.

Oliver’s true passion lies in helping Digital Health companies bring their innovative software to patients’ computers and smartphones in a safe and efficient manner. With his expertise and guidance, companies can rest assured that their products will be approved quickly while meeting all necessary regulations.

Oliver Hilgers

Head of CE plus: Digital Health & Innovation