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 navigating quality management systems (QMS) and regulatory compliance. They specialize in creating audit-ready QMS, developing risk management platforms, and preparing for FDA and ISO 13485 audits. Their services are designed to help clients achieve and maintain compliance with stringent regulatory requirements.
**Who they are**
Rook Quality Systems is a consultancy focused on quality management and regulatory affairs for the medical device industry.
**Expertise & scope**
* Guidance on Quality Management Systems (QMS)
* Creation of audit-ready QMS documentation
* Development of risk management platforms
* Preparation for FDA audits
* Preparation for ISO 13485 audits
* Support for regulatory compliance
**Reputation / proof points**
* Coverage across the US
* Services delivered in English
**Who they are**
Rook Quality Systems is a consultancy focused on quality management and regulatory affairs for the medical device industry.
**Expertise & scope**
* Guidance on Quality Management Systems (QMS)
* Creation of audit-ready QMS documentation
* Development of risk management platforms
* Preparation for FDA audits
* Preparation for ISO 13485 audits
* Support for regulatory compliance
**Reputation / proof points**
* Coverage across the US
* Services delivered in English
Additional information
Rook Quality Systems focuses on practical application of QMS principles to ensure readiness for regulatory inspections. They assist companies in building robust systems that not only meet compliance mandates but also enhance operational efficiency. Engagement typically involves a thorough assessment of existing QMS, followed by targeted development and implementation of improvements. Clients can expect support in areas such as documentation, risk management, and audit preparation, tailored to their specific product and market needs.
Key Highlights
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Specializes in creating audit-ready Quality Management Systems (QMS).
Source
“They specialize in creating audit-ready QMS, risk management platforms, and preparing for FDA and ISO 13485 audits.”
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Provides expert guidance for medical device companies on regulatory compliance.
Source
“Rook Quality Systems offers expert guidance for medical device companies navigating quality management systems (QMS) and regulatory compliance.”
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Focuses on preparation 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.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device companies seeking QMS and regulatory compliance support
- Organizations preparing for FDA or ISO 13485 audits
How engagement typically works
- Consultative guidance
- System development and implementation
Typical deliverables
- Audit-ready QMS documentation
- Risk management platforms
- Inspection readiness plans
Good to know
- Best when clients require specialized expertise in FDA and ISO 13485 compliance
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
