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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 st...

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Principais autores: Danica Marinac-Dabic, Philip Goodney, Laura Elisabeth Gressler, Susan dosReis, C. Daniel Mullins, Fadia Shaya
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group 2022-07-01
coleção:BMJ Surgery, Interventions, & Health Technologies
Acesso em linha:https://sit.bmj.com/content/4/1/e000106.full
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