Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
© 2021 Kheir et al..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Medical devices (Auckland, N.Z.) - 14(2021) vom: 22., Seite 313-319 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kheir, Omar [VerfasserIn] |
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| Links: |
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| Themen: |
Compliance |
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| Anmerkungen: |
Date Revised 28.10.2021 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.2147/MDER.S320583 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM332417239 |
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| 520 | |a 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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