TY  - JOUR
N2  - 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.
A1  -  Adalbert Lívia
A1  -  Kanti S P Yamini
A1  -  Jójártné Laczkovich Orsolya
A1  -  Akel Hussein
A1  -  Pannonhalminé Csóka Ildikó
JF  - BIOMEDICINES
IS  - 11
TI  - Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe
AV  - public
UR  - https://doi.org/10.3390/biomedicines10112947
VL  - 10
SN  - 2227-9059
Y1  - 2022///
ID  - publicatio36313
EP  - 21
ER  -