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Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed
Livia Adalbert1, S P Yamini Kanti1, Orsolya Jójárt-Laczkovich1
1Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös Utca 6, H-6720 Szeged, Hungary.
Abstract:
The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic. This review aims to provide an update on the current progress and emerging opportunities for additive manufacturing following the introduction of the new medical device regulation (MDR) within the EU. The advent of early-phase implementation of the Quality by Design (QbD) quality management framework in MD development is a focal point. The application of a regulatory supported QbD concept will ensure successful MD development, as well as pointing out the current challenges of 3D bioprinting. Utilizing a QbD scientific and risk-management approach ensures the acceleration of MD development in a more targeted way by building in all stakeholders' expectations, namely those of the patients, the biomedical industry, and regulatory bodies.
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