Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance

INTRODUCTION: The EU Medical Device Regulation 2017/745 defines new rules for the certification and post-market surveillance of medical devices (MD), including an additional review by Expert Panels of clinical evaluation data for high-risk MD if reports and alerts suggest possibly associated increas...

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Detalles Bibliográficos
Autores principales: Ren, Yijun, Bertoldi, Michele, Fraser, Alan G., Caiani, Enrico Gianluca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10133046/
https://www.ncbi.nlm.nih.gov/pubmed/36652105
http://dx.doi.org/10.1007/s43441-022-00493-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10133046/
https://www.ncbi.nlm.nih.gov/pubmed/36652105
http://dx.doi.org/10.1007/s43441-022-00493-y

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