About
Rook Quality Systems provides quality systems and regulatory consulting services for medical device companies, supporting class I–III devices including SaMD and IVDs. The firm offers tailored Quality Management System (QMS) development and implementation, Design History Files (DHF) and Technical Files (TF) support, and audit support for FDA, Notified Body, and MDSAP audits. Rook lists expertise in FDA regulations, ISO 13485:2016, ISO 14971, MDR/IVDR conformity, 21 CFR 820, 510(k) submissions, Design Control, Risk Management, CAPA, complaint handling, supplier approval, verification and validation. The company also develops customized quality training and assists with international product registration and post-market monitoring for medical device clients.
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