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

Omar Kheir, Sam Smedts, Alexis Jacoby, Stijn Verwulgen Department of Product Development, Faculty of Design Sciences, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir Tel +31657019567Email Omar.Kheir@student.uantwerpen.beAbstract: Start-ups that are involved in the development of me...

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Autores principales:	Kheir O, Smedts S, Jacoby A, Verwulgen S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	iso innovation medical start-up quality compliance documentation Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/46f484c82f2e47ad95192fb96687b92d
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spelling	oai:doaj.org-article:46f484c82f2e47ad95192fb96687b92d2021-12-02T17:16:00ZEfficient Quality Management in MedTech Start-Ups (Based on ISO 13485)1179-1470https://doaj.org/article/46f484c82f2e47ad95192fb96687b92d2021-10-01T00:00:00Zhttps://www.dovepress.com/efficient-quality-management-in-medtech-start-ups-based-on-iso-13485-peer-reviewed-fulltext-article-MDERhttps://doaj.org/toc/1179-1470Omar Kheir, Sam Smedts, Alexis Jacoby, Stijn Verwulgen Department of Product Development, Faculty of Design Sciences, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir Tel +31657019567Email Omar.Kheir@student.uantwerpen.beAbstract: 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.Keywords: ISO, innovation, medical, start-up, quality, compliance, documentationKheir OSmedts SJacoby AVerwulgen SDove Medical Pressarticleisoinnovationmedicalstart-upqualitycompliancedocumentationMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 14, Pp 313-319 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	iso innovation medical start-up quality compliance documentation Medical technology R855-855.5
spellingShingle	iso innovation medical start-up quality compliance documentation Medical technology R855-855.5 Kheir O Smedts S Jacoby A Verwulgen S Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
description	Omar Kheir, Sam Smedts, Alexis Jacoby, Stijn Verwulgen Department of Product Development, Faculty of Design Sciences, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir Tel +31657019567Email Omar.Kheir@student.uantwerpen.beAbstract: 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.Keywords: ISO, innovation, medical, start-up, quality, compliance, documentation
format	article
author	Kheir O Smedts S Jacoby A Verwulgen S
author_facet	Kheir O Smedts S Jacoby A Verwulgen S
author_sort	Kheir O
title	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_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_sort	efficient quality management in medtech start-ups (based on iso 13485)
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/46f484c82f2e47ad95192fb96687b92d
work_keys_str_mv	AT kheiro efficientqualitymanagementinmedtechstartupsbasedoniso13485 AT smedtss efficientqualitymanagementinmedtechstartupsbasedoniso13485 AT jacobya efficientqualitymanagementinmedtechstartupsbasedoniso13485 AT verwulgens efficientqualitymanagementinmedtechstartupsbasedoniso13485
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Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)

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