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

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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Bibliographic Details
Main Authors: Staci J. Kearney, Amanda Lowe, Jochen K. Lennerz, Anil Parwani, Marilyn M. Bui, Katy Wack, Gina Giannini, Esther Abels
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-11-01
Series:Frontiers in Medicine
Subjects:
regulatory strategy
clinical affairs
total product life cycle
in vitro diagnostics development
digital pathology
business strategy
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.765385/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2021.765385/full

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