Creation of objective performance criteria among medical devices

OBJECTIVES: Objective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key s...

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Detalles Bibliográficos
Autores principales: Gressler, Laura Elisabeth, Marinac-Dabic, Danica, dosReis, Susan, Goodney, Philip, Mullins, C. Daniel, Shaya, Fadia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345051/
https://www.ncbi.nlm.nih.gov/pubmed/35989873
http://dx.doi.org/10.1136/bmjsit-2021-000106

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345051/
https://www.ncbi.nlm.nih.gov/pubmed/35989873
http://dx.doi.org/10.1136/bmjsit-2021-000106

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