Practical guidance for researchers and engineers to introduce your MedTech innovation to the European market (MDR prove)

Rudolf M. Verdaasdonk; Keshen Mathura; Lisette van Gemert; Saskia Kelder

doi:10.1117/12.2649845

6 March 2023 Practical guidance for researchers and engineers to introduce your MedTech innovation to the European market (MDR prove)

Rudolf M. Verdaasdonk, Keshen Mathura, Lisette van Gemert, Saskia Kelder

Author Affiliations +

Proceedings Volume PC12370, Design and Quality for Biomedical Technologies XVI; PC1237003 (2023) https://doi.org/10.1117/12.2649845
Event: SPIE BiOS, 2023, San Francisco, California, United States

Abstract

The Medical Devices Regulations (MDR) in Europe have a major impact on medical devices and software developed in research institutes. A strategic program at the University of Twente supports researchers with practical formats of the Investigational Medical Device Dossier IMDD including risk assessment and ethical approval for clinical studies. The R&D facilities have a QMS in the spirit of ISO 9001 and 13485 to ease the transfer to a commercial partner or spin-off company. A maturity scan helps researchers to determine ‘missing’ parts for successful implementation of a medical device to the market. These practical tools accelerate the successful implementation of medtech innovations to the health market.

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Citation Download Citation

Rudolf M. Verdaasdonk, Keshen Mathura, Lisette van Gemert, and Saskia Kelder "Practical guidance for researchers and engineers to introduce your MedTech innovation to the European market (MDR prove)", Proc. SPIE PC12370, Design and Quality for Biomedical Technologies XVI, PC1237003 (6 March 2023); https://doi.org/10.1117/12.2649845

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