Rook Quality Systems

Rook Quality Systems supports medical device and SaMD teams with QMS design and management, audit readiness, CAPA, risk documentation, and regulatory submissions. Its clinical services cover protocol development, human factors validation, study oversight, and submission-ready reporting.

QMS, CAPA and Document Controls

• Build and run medical device QMS programs through custom design, implementation, gap assessment, compliance support, and ongoing fractional quality management.
• Write and maintain SOPs, work instructions, and other controlled documents, and resolve quality issues through CAPA completion, nonconformance handling, change management, and customer-feedback workflows.
• Train client teams on quality-compliance best practices through expert-led sessions.

Regulatory and Clinical Planning

• Develop device regulatory strategies, prepare FDA pre-submission meetings, and support 510(k), product registration, and other market-entry activities.
• Design clinical protocols, prepare IRB/IDE materials, and oversee CRO, lab, and platform coordination during active studies.

Validation, Risk and Inspection Readiness

• Prepare clients for audits and inspections through internal audit execution, gap identification, remediation planning, and on-site or remote support.
• Validate equipment, equipment software, facilities, manufacturing processes, and sterilization with customized protocols, reports, and client-site execution.
• Support human factors validation with use-related hazard analyses, human factors protocols, and guidance of formative and summative usability testing.

Best Fit

• Medical device, SaMD, and IVD companies needing hands-on quality-system ownership, regulatory planning, clinical-study support, or validation services.
• Teams that need support with DHF and technical-file maintenance, risk documentation, cybersecurity records, or submission-ready clinical reporting.