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5 articles related to "Quality Management System Qms"

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Articles

Methods

Published on 05 Aug 2025

Implementation of a quality management system for decentralized manufacturing of cell and gene therapy products - technical and regulatory considerations

in Regulatory Science

Heiko von der Leyen
Julio Delgado
Chaya Mazouz
Michael Schmitt
Vered Caplan

Frontiers in Medicine

doi 10.3389/fmed.2025.1591751

3,531 views
1 citation

Perspective

Published on 06 Jul 2022

A Perspective on a Quality Management System for AI/ML-Based Clinical Decision Support in Hospital Care

in Health Informatics

Richard Bartels
Jeroen Dudink
Saskia Haitjema
Daniel Oberski
Annemarie van ‘t Veen

Frontiers in Digital Health

doi 10.3389/fdgth.2022.942588

10,985 views
27 citations

Original Research

Published on 01 Apr 2025

Applying and validating a quality management system for in-house developed medical software

in Health Technology Implementation

Vera Lagerburg
Michelle van den Boorn
Reinier F. Crane
Koen Welvaars
Jaap M. Groen

Frontiers in Digital Health

doi 10.3389/fdgth.2025.1461107

3,007 views
1 citation

Original Research

Published on 26 Jun 2019

Biobank Quality Management in the BBMRI.be Network

in Translational Medicine

Loes Linsen
Veronique T'Joen
Catherine Van Der Straeten
Kristel Van Landuyt
Etienne Marbaix
Sofie Bekaert
Nadine Ectors

Frontiers in Medicine

doi 10.3389/fmed.2019.00141

10,463 views
17 citations

Original Research

Published on 29 Jul 2021

Epilepsy Personal Assistant Device—A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation

in Epilepsy

Tal Pal Attia
Daniel Crepeau
Vaclav Kremen
Mona Nasseri
Hari Guragain
Steven W. Steele
Vladimir Sladky
Petr Nejedly
Filip Mivalt
Jeffrey A. Herron

Frontiers in Neurology

doi 10.3389/fneur.2021.704170

9,376 views
39 citations