Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

Manufacturers of pathology imaging devices and associated software engage regulatory affairs and clinical affairs (RACA) throughout the Total Product Life Cycle (TPLC) of regulated products. A number of manufacturers, pathologists, and end users are not familiar with how RACA involvement benefits ea...

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Autores principales: Staci J. Kearney, Amanda Lowe, Jochen K. Lennerz, Anil Parwani, Marilyn M. Bui, Katy Wack, Gina Giannini, Esther Abels
Formato: article
Lenguaje:EN
Publicado: Frontiers Media S.A. 2021
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Acceso en línea:https://doaj.org/article/34f8f7360ab14310a50c7eddd8b3501f
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