Ready for Quality Leadership That Scales With You?
If your organization needs experienced quality leadership without committing to a full-time hire, Rook’s fractional model provides structure, accountability, and measurable progress.
Fractional Quality Management Support
Proven Quality Leadership Without the Full-Time Hire
Growing medical device and life science companies eventually reach a point where quality can no longer be handled informally. Processes become more complex, expectations increase, and the cost of mistakes rises quickly.
At the same time, hiring a full-time Head of Quality is not always practical.
Rook Quality Systems’ Fractional Quality Management Support gives you access to senior-level quality leadership on demand, without the cost, ramp time, or long-term commitment of a full-time hire.
We embed directly into your organization to own, maintain, and strengthen your Quality Management System, helping you stay compliant, audit-ready, and positioned to scale with confidence.
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End-To-End Clinical Trial Support
For Medical Devices
We specialize in providing clinical trial support services rooted in regulatory, quality, and compliance expertise. From early protocol planning to submission-ready documentation, Rook helps you build a rock-solid foundation for clinical success.
Step 1
Regulatory Planning & Study Design
Lay the foundation for a successful clinical or usability study with strategic regulatory insight.
- Initial regulatory review to determine validation study requirements
- Support for FDA pre-submission meetings to align on study scope
- Guidance on IRB and/or IDE approval requirements
Step 2
Protocol & Documentation Development
Ensure your study is supported by strong, submission-ready documentation.
- Drafting of clinical and usability study protocols
- Preparation of supporting materials for IRB and/or IDE submissions
- Survey creation and documentation tailored to study endpoints
Step 3
Usability Validation & Risk Analysis
Demonstrate safe, effective use with expert-led human factors validation.
- Usability risk analysis and use-related hazard assessments
- Support for usability protocol design and execution
- Oversight of formative and summative usability testing
Step 4
Clinical Execution & Real-Time Monitoring
Accelerate your study timeline with decentralized trials and live data insights.
- Access to Rook's decentralized clinical trial (DCT) partner platform
- Real-time clinical data monitoring throughout the study
- Issue tracking and compliance oversight during trial execution
Step 5
Final Reporting & Submission Support
Translate study results into regulatory-ready submissions.
- Clinical data analysis and interpretation
- Development of the final clinical or usability validation report
- Integration of results into FDA submissions
What Is Fractional Quality Management?
Fractional Quality Management provides experienced quality leadership on a flexible, part-time basis. Instead of ad-hoc consulting or reactive support, Rook acts as an extension of your internal team, taking accountability for ongoing quality execution.
Rather than responding only when issues arise, fractional support keeps quality activities moving forward consistently throughout the year.
This model is ideal for organizations that:
- Are scaling toward commercialization or expansion
- Need experienced quality oversight, but not a full-time role
- Want predictable, structured quality execution
- Are preparing for audits, submissions, or inspections
Step 1
Regulatory Planning & Study Design
Lay the foundation for a successful clinical or usability study with strategic regulatory insight.
- Initial regulatory review to determine validation study requirements
- Support for FDA pre-submission meetings to align on study scope
- Guidance on IRB and/or IDE approval requirements
Step 2
Protocol & Documentation Development
Ensure your study is supported by strong, submission-ready documentation.
- Drafting of clinical and usability study protocols
- Preparation of supporting materials for IRB and/or IDE submissions
- Survey creation and documentation tailored to study endpoints
Step 3
Usability Validation & Risk Analysis
Demonstrate safe, effective use with expert-led human factors validation.
- Usability risk analysis and use-related hazard assessments
- Support for usability protocol design and execution
- Oversight of formative and summative usability testing
Step 4
Clinical Execution & Real-Time Monitoring
Accelerate your study timeline with decentralized trials and live data insights.
- Access to Rook's decentralized clinical trial (DCT) partner platform
- Real-time clinical data monitoring throughout the study
- Issue tracking and compliance oversight during trial execution
Step 5
Final Reporting & Submission Support
Translate study results into regulatory-ready submissions.
- Clinical data analysis and interpretation
- Development of the final clinical or usability validation report
- Integration of results into FDA submissions
How Rook Supports Your Quality System
Rook’s fractional model is built around structured, recurring ownership, not generic advisory hours. Support is tailored to your lifecycle stage and mapped across the calendar year to ensure nothing is overlooked.
Core Areas of Fractional Quality Support
Quality System Maintenance & Oversight
- QMS documentation management and updates
- SOPs, work instructions, document control, and standards alignment
- Annual quality planning, objectives, and schedules
Audit & Inspection Readiness
- Internal audit planning and execution
- Audit preparation and on-site or remote support
- Gap identification and remediation planning
CAPA, Risk & Compliance Management
- CAPA and nonconformance management
- Risk management and risk file maintenance
- GSPR alignment and ongoing compliance review
Design & Product Lifecycle Support
- Design controls and technical file support
- Design and risk reviews
- Product realization and change management
Supplier & Operational Quality
- Supplier assessment, evaluation, and quality agreements
- Manufacturing, incoming inspection, and QC oversight
- Calibration, software, and production quality support
Post-Market & Regulatory Support
- Complaints handling and post-market surveillance
- Recall readiness and support
- Ongoing regulatory review and planning
This structured approach keeps your QMS current, audit-ready, and aligned with your business goals, rather than drifting into reactive maintenance.
Why Companies Choose Fractional Over Full-Time
Hiring a full-time quality leader is expensive, time-consuming, and often unnecessary during growth phases when needs fluctuate.
With Rook’s fractional model, companies gain:
- Senior expertise without senior-level overhead
- Faster onboarding than a full-time hire
- Flexibility to scale support as the business evolves
- A team-backed approach rather than a single point of failure
- Proven frameworks, tools, and execution models
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Who This Is For
Rook’s Fractional Quality Management Support is a strong fit for:
- Medical device startups and scaling companies
- Organizations preparing for commercialization
- Companies maintaining compliance post-clearance
- Teams without dedicated senior quality leadership
- Organizations navigating audits, growth, or operational change