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
**Who they are**
Rook Quality Systems provides expert guidance for medical device companies focused on quality management systems and regulatory compliance.
**Expertise & scope**
* Creating audit-ready Quality Management Systems (QMS)
* Developing risk management platforms
* Preparing for FDA and ISO 13485 audits
* Navigating QMSR transition requirements
**Reputation / proof points**
* Specializes in US regulatory coverage.
Rook Quality Systems provides expert guidance for medical device companies focused on quality management systems and regulatory compliance.
**Expertise & scope**
* Creating audit-ready Quality Management Systems (QMS)
* Developing risk management platforms
* Preparing for FDA and ISO 13485 audits
* Navigating QMSR transition requirements
**Reputation / proof points**
* Specializes in US regulatory coverage.
Additional information
Rook Quality Systems focuses on preparing medical device companies for regulatory scrutiny. Their services are designed to ensure that quality management systems are robust and compliant with current standards, particularly in anticipation of FDA inspections and ISO 13485 audits. They emphasize creating systems that are not only compliant but also audit-ready, streamlining the inspection process for their clients. Engagement typically involves a deep dive into existing QMS processes to identify gaps and implement necessary improvements.
Key Highlights
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Specializes in preparing medical device companies for FDA and ISO 13485 audits.
Source
“They specialize in creating audit-ready QMS, risk management platforms, and preparing for FDA and ISO 13485 audits.”
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Offers expert guidance for navigating quality management systems (QMS) and regulatory compliance.
Source
“Rook Quality Systems offers expert guidance for medical device companies navigating quality management systems (QMS) and regulatory compliance.”
Certifications & Trust Signals
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Established provider of QMSR transition and inspection readiness services.
Source
“QMSR transition & Inspection Readiness provider”
Buyer Snapshot
Best for
- Medical device companies needing QMS and regulatory compliance support
- Organizations preparing for FDA or ISO 13485 audits
How engagement typically works
- Guidance on audit readiness
- Development of compliant QMS
Typical deliverables
- Audit-ready QMS
- Risk management platforms
- Inspection preparation
Good to know
- Primarily US coverage
HQ:
Dunwoody, US
Languages:
English
Timezones:
EST, PST
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, Internal Audit Program Upgrade, Mock FDA Inspection, SOP / Documentation Remediation
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
