PubMed

Medical device similarity analysis: a promising approach to medical device equivalence regulation.

PMID: 39300713 · 2024-09-19

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학술지Expert review of medical devices

연도2024-09-19

PMID39300713

초록

This study aims to facilitate the identification of similar devices for both, the European Medical Device Regulation (MDR) and the US 510(k) equivalence pathway by leveraging existing data. Both are related to the regulatory pathway of read across for chemicals, where toxicological data from a known substance is transferred to one under investigation, as they aim to streamline the accreditation process for new devices and chemicals. This study employs latent semantic analysis to generate similar

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