Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)

Start-ups that are involved in the development of medical devices play a key role in innovation, yet among the several limitations they encounter, they suffer a lack of knowledge in quality management. This lack may create a challenge that could hinder or limit their success. This paper seeks to pre...

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Detalles Bibliográficos
Autores principales: Kheir, Omar, Smedts, Sam, Jacoby, Alexis, Verwulgen, Stijn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2021
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8526944/
https://www.ncbi.nlm.nih.gov/pubmed/34703329
http://dx.doi.org/10.2147/MDER.S320583
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author Kheir, Omar
Smedts, Sam
Jacoby, Alexis
Verwulgen, Stijn
author_facet Kheir, Omar
Smedts, Sam
Jacoby, Alexis
Verwulgen, Stijn
author_sort Kheir, Omar
collection PubMed
description Start-ups that are involved in the development of medical devices play a key role in innovation, yet among the several limitations they encounter, they suffer a lack of knowledge in quality management. This lack may create a challenge that could hinder or limit their success. This paper seeks to present an overview and act as a guideline for the required documentation to establish a quality management system for start-ups in medical devices development, based on a case-studied start-up, in accordance with ISO 13485. Using this case study along with the actual ISO 13485 standard document, can support medical devices start-ups in their ISO compliance and certification journey.
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spelling pubmed-85269442021-10-25 Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485) Kheir, Omar Smedts, Sam Jacoby, Alexis Verwulgen, Stijn Med Devices (Auckl) Perspectives Start-ups that are involved in the development of medical devices play a key role in innovation, yet among the several limitations they encounter, they suffer a lack of knowledge in quality management. This lack may create a challenge that could hinder or limit their success. This paper seeks to present an overview and act as a guideline for the required documentation to establish a quality management system for start-ups in medical devices development, based on a case-studied start-up, in accordance with ISO 13485. Using this case study along with the actual ISO 13485 standard document, can support medical devices start-ups in their ISO compliance and certification journey. Dove 2021-10-15 /pmc/articles/PMC8526944/ /pubmed/34703329 http://dx.doi.org/10.2147/MDER.S320583 Text en © 2021 Kheir et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Perspectives
Kheir, Omar
Smedts, Sam
Jacoby, Alexis
Verwulgen, Stijn
Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
title Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
title_full Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
title_fullStr Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
title_full_unstemmed Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
title_short Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
title_sort efficient quality management in medtech start-ups (based on iso 13485)
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8526944/
https://www.ncbi.nlm.nih.gov/pubmed/34703329
http://dx.doi.org/10.2147/MDER.S320583
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