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Rook Quality Systems provides quality management and regulatory compliance consulting services to early-stage and established medical device companies, specializing in FDA regulations, MDSAP audits, ISO 13485 compliance, MDR conformity, and support for Software as a Medical Device (SaMD) and In Vitro Diagnostics (IVD). Their expertise helps clients efficiently bring devices to market by building compliant quality management systems[1][3][4].
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