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PubMed

Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies.

PMID: 39862365 ·

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RevistaJournal of medical systems
Año
PMID39862365

Resumen

Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This article explores the historical evolu

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