PubMed

Química Analítica en la Ciencia Regulatoria de los Dispositivos Médicos

PMID: 29579404 · 2018-03-26

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RevistaAnnual review of analytical chemistry (Palo Alto, Calif.)

Año2018-03-26

PMID29579404

Resumen

In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays

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