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Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders
BACKGROUND: Medical device certification has undergone significant changes in recent years. However, exploration of stakeholder experiences remains relatively limited, particularly in the context of software as a medical device. This study sought to explore stakeholder experiences of medical device...
Autores principales: | Baines, Rebecca, Hoogendoorn, Petra, Stevens, Sebastian, Chatterjee, Arunangsu, Ashall-Payne, Liz, Andrews, Tim, Leigh, Simon |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531632/ https://www.ncbi.nlm.nih.gov/pubmed/36194368 http://dx.doi.org/10.1007/s43441-022-00463-4 |
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