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Title
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Efficient quality management in MedTech Start-Ups (based on ISO 13485)
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Author
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Abstract
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| 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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Language
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English
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Source (journal)
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Medical Devices: Evidence and Research
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Publication
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2021
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ISSN
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1179-1470
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DOI
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10.2147/MDER.S320583
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Volume/pages
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14
(2021)
, p. 313-319
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ISI
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000708746000001
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Pubmed ID
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34703329
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Full text (Publisher's DOI)
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Full text (open access)
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