relation: http://publicatio.bibl.u-szeged.hu/36313/
title: Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe
creator:  Adalbert Lívia
creator:  Kanti S P Yamini
creator:  Jójártné Laczkovich Orsolya
creator:  Akel Hussein
creator:  Pannonhalminé Csóka Ildikó
subject: 03.01. Általános orvostudomány
description: 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.
date: 2022
type: Folyóiratcikk
type: PeerReviewed
format: text
identifier: http://publicatio.bibl.u-szeged.hu/36313/1/Article2.pdf
identifier:     Adalbert Lívia;  Kanti S P Yamini;  Jójártné Laczkovich Orsolya;  Akel Hussein;  Pannonhalminé Csóka Ildikó: Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe.   BIOMEDICINES, 10 (11).   ISSN 2227-9059 (2022)     
identifier: doi:10.3390/biomedicines10112947
relation: https://doi.org/10.3390/biomedicines10112947
relation: 33256091
language: eng