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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 Regulation2023 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Florent J.L.A. Vanstapel, Matthias Orth, Thomas Streichert, Ettore Capoluongo, Wytze P. Oosterhuis, Hikmet Can Çubukçu, +10 more
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