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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation

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Clinical Chemistry and Laboratory Medicine, 61, 608-626
Clinical Chemistry and Laboratory Medicine, 61(4). WALTER DE GRUYTER GMBH

Contains fulltext : 290896.pdf (Publisher’s version ) (Closed access) The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::93d8bcb2ad3a7a33f7eea85a887c25f4
https://hdl.handle.net/1887/3590515

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