Rook Quality Systems
Rook Quality Systems offers expert guidance for medical device companies navigating quality management systems (QMS) and regulatory compliance. They specialize in creating audit-ready QMS, risk management platforms, and preparing for FDA and ISO 13485 audits.
Rook Quality Systems provides specialized consulting services for medical device manufacturers seeking to establish and maintain robust quality management systems (QMS). They offer tailored solutions for QMS design and management, ensuring compliance with FDA regulations and ISO 13485 standards. Rook's expertise extends to developing comprehensive risk management platforms, including PHAs and FMEAs, and assisting with the creation of device Master Files (MDF) and Technical Files (TF). Their team of certified auditors and experienced quality engineers are adept at preparing companies for audits, offering audit support and readiness reviews. Rook Quality Systems also assists with Software as a Medical Device (SaMD) QMS and 510(k) submissions. They focus on creating efficient, easy-to-maintain systems that are audit-ready and continually updated to ensure compliance, helping clients avoid costly delays and confidently navigate the complex regulatory landscape.
About
Rook Quality Systems provides expert guidance for medical device companies focused on quality management systems (QMS) and regulatory compliance. They specialize in developing audit-ready QMS, implementing risk management platforms, and preparing organizations for inspections by regulatory bodies such as the FDA and for ISO 13485 certification.
**Who they are**
Rook Quality Systems is a consultancy dedicated to helping medical device manufacturers achieve and maintain compliance with stringent quality and regulatory standards.
**Expertise & scope**
* Development of audit-ready Quality Management Systems (QMS)
* Implementation of risk management platforms
* Preparation for FDA inspections and ISO 13485 audits
* Guidance on navigating regulatory compliance for medical devices
**Reputation / proof points**
* Coverage across the United States
* Services delivered in English
**Who they are**
Rook Quality Systems is a consultancy dedicated to helping medical device manufacturers achieve and maintain compliance with stringent quality and regulatory standards.
**Expertise & scope**
* Development of audit-ready Quality Management Systems (QMS)
* Implementation of risk management platforms
* Preparation for FDA inspections and ISO 13485 audits
* Guidance on navigating regulatory compliance for medical devices
**Reputation / proof points**
* Coverage across the United States
* Services delivered in English
Additional information
For medical device companies preparing for regulatory scrutiny, Rook Quality Systems focuses on building robust quality management systems that stand up to audits. Their approach emphasizes practical implementation of risk management principles and documentation that meets FDA and ISO 13485 requirements. Buyers can expect a structured process aimed at ensuring their QMS is not only compliant but also audit-ready, minimizing potential findings during inspections. Engagement typically involves close collaboration to tailor solutions to the specific needs and existing infrastructure of the medical device company.
Key Highlights
-
Specializes in preparing medical device companies for FDA inspections.
Source
“preparing for FDA and ISO 13485 audits”
-
Focuses on creating audit-ready Quality Management Systems (QMS).
Source
“creating audit-ready QMS”
-
Offers expertise in risk management platforms for medical devices.
Source
“risk management platforms”
Certifications & Trust Signals
-
Provides services across the United States.
Source
“Coverage: US”
Buyer Snapshot
Best for
- Medical device companies needing QMS development
- Firms preparing for FDA inspections
- Organizations seeking ISO 13485 compliance
How engagement typically works
- Collaborative project-based work
- Guidance and implementation support
Typical deliverables
- Audit-ready QMS documentation
- Risk management system implementation
- Inspection readiness plans
Good to know
- Best when seeking specialized expertise in FDA and ISO 13485 compliance for medical devices.
HQ:
Dunwoody, US
Languages:
English
Timezones:
EST, PST
Claim status:
Listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, IVD
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Service Types:
QMSR/ISO 13485 Gap Assessment, SOP / Documentation Remediation, Internal Audit Program Upgrade, Mock FDA Inspection, 483 Response & Remediation Support
Earliest Start:
flexible
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
