Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).

Spitzenberger, Folker; Patel, Jaimin; Gebuhr, Inga; Kruttwig, Klaus; Safi, Abdulrahim; Meisel, Christian

Spitzenberger, Folker; Patel, Jaimin; Gebuhr, Inga; Kruttwig, Klaus; Safi, Abdulrahim; Meisel, Christian.

Afiliação

Spitzenberger F; Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck, Mönkhofer Weg 239, 23562, Lübeck, Germany. folker.spitzenberger@th-luebeck.de.
Patel J; Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck, Mönkhofer Weg 239, 23562, Lübeck, Germany.
Gebuhr I; Labor Berlin - Charité Vivantes GmbH, Sylter Strasse 2, 13353, Berlin, Germany.
Kruttwig K; Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck, Mönkhofer Weg 239, 23562, Lübeck, Germany.
Safi A; Leibniz Institute of Photonic Technology E.V. Jena, Albert-Einstein-Str. 9, 07745, Jena, Germany.
Meisel C; Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck, Mönkhofer Weg 239, 23562, Lübeck, Germany.

Ther Innov Regul Sci ; 56(1): 47-64, 2022 01.

Article em En | MEDLINE | ID: mdl-34291407

Assuntos

Laboratórios; Kit de Reagentes para Diagnóstico; Padrões de Referência

Palavras-chave

Conformity assessment; IVDR; In-house IVD; LDT; Laboratory-developed tests; Validation

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Kit de Reagentes para Diagnóstico / Laboratórios Tipo de estudo: Diagnostic_studies / Prognostic_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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