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...

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Detalles Bibliográficos
Autores principales: Baines, Rebecca, Hoogendoorn, Petra, Stevens, Sebastian, Chatterjee, Arunangsu, Ashall-Payne, Liz, Andrews, Tim, Leigh, Simon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Original Research
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

Internet

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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