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MDR-prep

IT driven QMS-tool for MDR compliance of early-stage medical device development

Delft University of Technology (TU Delft)

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.

This application supports one aspect of this: A MDR-tool for compliance and a dedicated Quality Management System (QMS).

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.

By implementing a dedicated electronic MDR-regulation solution assures compliance to prevent obstacles at a later stage. Especially for research organisations the MDR-regulation has a significant impact, as this is where the idea, design and prototypes are being made and where the whole journey starts. MDR compliance is essential for medical products to make a chance for exploitation, commercialisation and market entry as all critical aspects regarding regulation, safety, and patient needs.

Applications closed on the 24th of January 2024 at 17:00 CET.

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Complear

Complear partners with Digital Health companies to bring medical device products to the market, either with boutique regulatory and compliance services for Medical Devices and IVDs focused on Digital Health and AI, either by building the future operating system for automating regulatory and compliance using a digital platform powered by Artificial Intelligence.

Complear is a solution to support compliance with Regulatory Requirements for research teams at universities, ensuring 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, Clinical Studies Submissions, powered by an AI copilot.

Complear is developing a Electronic Quality Management System and Electronic Technical Documentation platform for Digital Health and AI Startups. The challenge to develop a simplified solution that could be used in the beginning of the journey of many of the medical devices innovations at universities was a total fit for the mission of scaling access to expertise and knowledge in the regulatory area using digital tools.