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Delft University of Technology (TUD), is a leading technical university located in The Netherlands, contributing to solving global challenges by educating socially responsible engineers, expanding the frontiers of the engineering sciences.
TUD has a strong focus on research and education in the field of health technology, specialised in health technology, including Bioelectronics, Biomechanical Engineering, Imaging Physics, regenerative medicine, and medical robotics, including Master of Science programs in BioMedical Engineering and Technical Medicine. TUD collaborates with various research institutes, hospitals, and companies to develop innovative solutions to health-related problems e.g. the Medical Delta, a collaboration between TUD, Leiden University Medical Centre, and Erasmus MC and Convergence for Health & Technology, between Erasmus MC, EUR and TUD to cross-pollinate between ideas, procedures, instruments and products for which MDR requirements require alignment with legal obligations.
According to the European Commission, 500,000 medical devices are available on the European market and about 10,000 new medical devices are added every year. In Europe, an average of 1% of GDP is spent on healthcare. Annual per capita expenditure on medical technologies in Europe is about €225 (average according to MedTech Europe) these numbers warrant a proactive approach to secure this part of the EU market.
The MDR is a European Union (EU) regulation becoming applicable on 31 December 2027 for higher risk devices and on 31 December 2028 for medium and lower risk devices. To comply with the MDR, medical device designers and engineers are to provide extensive documentation, quality control evidence, prior to clinical evidence demonstrating the safety and efficacy of their product as part of these requirements. These requirements are time-consuming, costly. Hence, dedicated information, guidance, documentation and an electronical QMS are required to streamline and control this process, ensuring legal compliance to foster medical innovation technology transfer and uptake. With Universities it starts with awareness of and assessing requirements of adherence to MDR-regulation.
A dedicated electronic MDR-regulation solution ensures proactive compliance, preventing future obstacles. This is particularly crucial for research organizations, where medical product development begins. MDR compliance is essential for successful exploitation, commercialization, and market entry, addressing all critical aspects of regulation, safety, and patient needs.”
Complear partners with Digital Health companies to bring medical device products to market, either through boutique regulatory and compliance services for Medical Devices and IVDs focused on Digital Health and AI, or by building the future operating system for automating regulatory and compliance processes using a digital platform powered by Artificial Intelligence.
Complear provides a solution to support compliance with regulatory requirements for research teams at universities, offering guidance, training, and an online platform for tracking design and development to ensure readiness for translation from bench to market of medical devices. The solution includes support for technical documentation and clinical studies submissions, powered by an AI copilot.
Complear develops solutions to solve regulatory issues for Digital Health and AI startups, with an Electronic Quality Management System and an Electronic Technical Documentation platform. In addition, Complear develops a simplified solution for universities, solving the problem of early stage regulatory hurdles, thus expanding access to regulatory knowledge.
This project has received funding from the European Union’s Horizon Europe research and innovation programme under the Grant Agreement 101071212.
Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council and SMEs Executive Agency (EISMEA). Neither the European Union nor the granting authority can be held responsible for them.
