European health technology development is undergoing a transition, and new regulatory requirements are challenging companies to find effective solutions. Clinipower is participating in the EU project EU4MEDTECH, which is advancing the development of health technology.
EU4MEDTECH Project – Transformation of Medical Technology Evaluation
EU4MEDTECH is a 4-year Horizon Europe project that develops the evaluation and regulation of high-risk medical devices (MD) and in vitro diagnostic devices (IVD) across Europe.
The EU4MEDTECH framework is a lifecycle-based approach to the generation, assessment, and validation of clinical and performance evidence for innovative medical devices (MD), in vitro diagnostics (IVD), and medical software.
EU4MEDTECH enhances the evaluation of medical devices by providing a unified framework and digital platform, ensuring compliance with regulatory requirements, patient safety, and faster market access for innovative health technologies.
Clinipower’s Expertise in the EU4MEDTECH Project
Clinipower brings many years of experience in health technology development and regulatory compliance to the project. We have supported both startups and international companies in usability, clinical evidence, and quality management. Within the EU4MEDTECH project, we combine practical experience with theoretical expertise.
The regulation of medical devices, in vitro diagnostic devices, and medical software requires special attention, and we assist companies in navigating this complex environment.
Contact us today if your organization also needs expert support!
