Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders.

Baines, Rebecca; Hoogendoorn, Petra; Stevens, Sebastian; Chatterjee, Arunangsu; Ashall-Payne, Liz; Andrews, Tim; Leigh, Simon

Baines, Rebecca; Hoogendoorn, Petra; Stevens, Sebastian; Chatterjee, Arunangsu; Ashall-Payne, Liz; Andrews, Tim; Leigh, Simon.

Afiliação

Baines R; The Organisation for the Review of Care and Health Applications (ORCHA), Daresbury, WA4 4AB, UK.
Hoogendoorn P; University of Plymouth, Plymouth, PL4 8AA, UK.
Stevens S; Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, Netherlands.
Chatterjee A; The Organisation for the Review of Care and Health Applications (ORCHA), Daresbury, WA4 4AB, UK.
Ashall-Payne L; University of Plymouth, Plymouth, PL4 8AA, UK.
Andrews T; University of Leeds, Leeds, LS2 9JT, UK.
Leigh S; The Organisation for the Review of Care and Health Applications (ORCHA), Daresbury, WA4 4AB, UK.

Ther Innov Regul Sci ; 57(2): 238-250, 2023 03.

Article em En | MEDLINE | ID: mdl-36194368

Assuntos

Certificação; Qualidade da Assistência à Saúde; Pesquisa Qualitativa; Software

Palavras-chave

CE mark; Digital health; Medical devices; Regulation; UKCA

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Qualidade da Assistência à Saúde / Certificação Tipo de estudo: Qualitative_research Idioma: En Revista: Ther Innov Regul Sci Ano de publicação: 2023 Tipo de documento: Article

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google