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 and regulatory compliance. They specialize in developing audit-ready QMS, 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, ensuring their quality systems are robust and inspection-ready. They focus on practical solutions tailored to the specific needs of each medical device company.
Additional information
Rook Quality Systems assists medical device companies in preparing for regulatory inspections and transitioning to updated quality management system requirements. Their approach emphasizes building sustainable compliance programs that integrate seamlessly into a company's operations. They focus on actionable strategies to address potential findings and enhance overall quality system effectiveness.
Key Highlights
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Specializes in FDA QMSR Transition & Inspection Readiness for medical device companies.
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 creating audit-ready QMS and risk management platforms.
Source
“They specialize in creating audit-ready QMS, risk management platforms, and preparing for FDA and ISO 13485 audits.”
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Provides preparation services for FDA and ISO 13485 audits.
Source
“preparing for FDA and ISO 13485 audits.”
Certifications & Trust Signals
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Offers expert guidance in medical device quality management systems.
Source
“Rook Quality Systems offers expert guidance for medical device companies navigating quality management systems (QMS) and regulatory compliance.”
Buyer Snapshot
Best for
- Medical device companies seeking FDA QMSR transition support
- Organizations needing to prepare for ISO 13485 audits
- Companies aiming to establish audit-ready Quality Management Systems
How engagement typically works
- Consultative guidance on QMS and regulatory compliance
- Development of audit-ready systems and risk management platforms
- Preparation for FDA and ISO 13485 inspections
Typical deliverables
- Audit-ready QMS documentation
- Risk management frameworks
- Inspection readiness plans
- Guidance on QMSR transition
Good to know
- Best when companies require specialized expertise in medical device quality systems and FDA/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
