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Regulatory Assistregulatoryassist.com · Low evidenceRegulatory Assist is a medical device regulatory consulting firm that helps companies bring devices to market faster by delivering audit-ready ISO 14971 risk management, ISO 13485 quality systems, and FDA 510(k) submissions. They offer comprehensive regulatory solutions including RMF creation (plans, hazard analyses, FMEAs, reports), QMS gap assessments, SOP development, internal audits, CAPA management, predicate selection, testing plans, and eSTAR preparation. Based in Albuquerque, NM with a global client reach, they emphasize practical implementation backed by 20+ years of experience and a 95% first-round submission acceptance rate.
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