Finding our way in the <i>In Vitro</i> Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum.

Timmerman, Philip; Laurén, Anna; Nelson, Robert; Barfield, Matthew

Finding our way in the In Vitro Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum.

Timmerman, Philip; Laurén, Anna; Nelson, Robert; Barfield, Matthew.

Afiliación

Timmerman P; European Bioanalysis Forum, Havenlaan 86c b204, 1000, Brussels, Belgium.
Laurén A; MinervaX, 223 63 Lund, Sweden (Employed at the following address at the time of writing of this manuscript: Novo Nordisk A/S, Non-clinical & Clinical Assay Sciences, Global Discovery & Development Sciences, Global Drug Discovery, DK-2760, Maaløv, Denmark).
Nelson R; BioAgilytix Laboratories, 22339, Hamburg, Germany.
Barfield M; Roche Innovation Center Welwyn, Roche Pharma Research & Early Development, Welwyn Garden City, AL7 1TW, Hertfordshire, UK.

Bioanalysis ; 16(3): 117-120, 2024 Feb.

Article en En | MEDLINE | ID: mdl-38197373

Asunto(s)

Bioensayo; Juego de Reactivos para Diagnóstico; Europa (Continente)

Palabras clave

Bioanalysis; Clinical studies; IVDR; Regulated; Scope definition

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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Juego de Reactivos para Diagnóstico / Bioensayo Tipo de estudio: Diagnostic_studies País/Región como asunto: Europa Idioma: En Revista: Bioanalysis Año: 2024 Tipo del documento: Article

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