A case study: Re-evaluating the biological risk following a processing aid change on a marketed cardiovascular implant device

Per ISO 10993-1:2018, a processing change to a medical device requires re-evaluation of biological risk. Here, we present the biological evaluation of a marketed cardiovascular implant following a detergent formulation change. This change was initially assessed through a qualitative toxicological ri...

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Detalles Bibliográficos
Autores principales: Hsia, Frances K., Stornetta, Alessia, Soucy, Nicole V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Medical Technology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9742234/
https://www.ncbi.nlm.nih.gov/pubmed/36518990
http://dx.doi.org/10.3389/fmedt.2022.1006984

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9742234/
https://www.ncbi.nlm.nih.gov/pubmed/36518990
http://dx.doi.org/10.3389/fmedt.2022.1006984

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