Rook Quality Systems
Rook Quality Systems is a provider of medical device quality consulting, specializing in regulatory compliance, quality management systems, and supporting companies in achieving FDA, ISO, MDR, and IVDR standards. Their mission is to help clients bring medical devices to market efficiently and compliantly, leveraging extensive industry expertise and a diverse team of certified professionals. They offer a wide range of services including regulatory support, QMS development, clinical trial support, and specialized solutions like QuickStart packages and eSTAR playbooks to accelerate market entry.
Industries
Nr. of Employees
small (1-50)
Products
Tools & Templates collection
A set of QMS and regulatory documentation templates and tools intended to accelerate QMS implementation, complaint handling, and submission preparation.
Complaint Log and Form template bundle
Customizable complaint log and form templates structured to meet regulatory complaint handling requirements for medical device and IVD manufacturers.
QuickStart early-stage MedTech package
An early-stage startup package that pairs a cloud-based eQMS deployment with a comprehensive documentation package, starter user licenses, and a monthly allotment of QA/RA support hours to accelerate QMS implementation.
eSTAR submission playbook (ebook)
A step-by-step playbook describing how to prepare and submit FDA template-based submissions, including guidance on required content, submission process, timelines, and practical tips for success.
At-home diagnostic launch solution
A packaged offering to support the development, validation, and market launch of at-home diagnostic tests, including regulatory strategy, remote clinical validation, and post-launch analytics integration.
Quality Systems Management
Expert quality systems management services providing dedicated quality personnel for medical device, SaMD, and IVD companies, covering both pre-market and post-market QMS activities.
Tools & Templates collection
A set of QMS and regulatory documentation templates and tools intended to accelerate QMS implementation, complaint handling, and submission preparation.
Complaint Log and Form template bundle
Customizable complaint log and form templates structured to meet regulatory complaint handling requirements for medical device and IVD manufacturers.
QuickStart early-stage MedTech package
An early-stage startup package that pairs a cloud-based eQMS deployment with a comprehensive documentation package, starter user licenses, and a monthly allotment of QA/RA support hours to accelerate QMS implementation.
eSTAR submission playbook (ebook)
A step-by-step playbook describing how to prepare and submit FDA template-based submissions, including guidance on required content, submission process, timelines, and practical tips for success.
At-home diagnostic launch solution
A packaged offering to support the development, validation, and market launch of at-home diagnostic tests, including regulatory strategy, remote clinical validation, and post-launch analytics integration.
Quality Systems Management
Expert quality systems management services providing dedicated quality personnel for medical device, SaMD, and IVD companies, covering both pre-market and post-market QMS activities.
Services
Design and implement audit-ready quality management systems tailored to device class and organizational needs; includes documentation templates, procedures, and ongoing maintenance.
Evaluate eQMS options, configure and deploy cloud-based eQMS applications, and provide licensing and ongoing QA/RA advisory to integrate the eQMS with quality and development processes.
Develop risk-management platforms and processes using PHAs and FMEAs across design, use, process, and software domains to document hazards and risk controls.
Provide internal audit services, pre-inspection preparation, and on-site or remote support during regulatory inspections to improve inspection outcomes and remediate nonconformances.
Prepare, review, and compile regulatory submissions including 510(k) and template-based submissions, and coordinate pre-submission interactions with regulators.
Create and maintain design control documentation, Design History Files, Technical Files, and support design transfer activities to manufacturing.
Design and implement audit-ready quality management systems tailored to device class and organizational needs; includes documentation templates, procedures, and ongoing maintenance.
Evaluate eQMS options, configure and deploy cloud-based eQMS applications, and provide licensing and ongoing QA/RA advisory to integrate the eQMS with quality and development processes.
Develop risk-management platforms and processes using PHAs and FMEAs across design, use, process, and software domains to document hazards and risk controls.
Provide internal audit services, pre-inspection preparation, and on-site or remote support during regulatory inspections to improve inspection outcomes and remediate nonconformances.
Prepare, review, and compile regulatory submissions including 510(k) and template-based submissions, and coordinate pre-submission interactions with regulators.
Create and maintain design control documentation, Design History Files, Technical Files, and support design transfer activities to manufacturing.
Expertise Areas
- Quality management system design and implementation
- eQMS selection, deployment, and configuration
- Regulatory submissions and strategy (510(k), pre-submissions, eSTAR, De Novo)
- Clinical trial strategy and execution for medical devices
Key Technologies
- Electronic quality management systems (cloud-based eQMS)
- IEC 62304-aligned software lifecycle processes
- AAMI TIR45 guidance for Agile medical software development
- ISO 13485 quality management framework
News & Updates
Discussion on the FDA’s ISO-13485 transition plan, its implications, and how it affects medical device companies.
Guidance on meeting ISO 13485-2016 requirements, timelines, and best practices.
Insights into regulatory expectations for SaMD, documentation, and compliance.
Understanding the changes imposed on SaMD under the new EU MDR regulation.
Guidance on supplier evaluation in compliance with FDA regulations.
Predictions and trends for medical device quality in 2024.
Discussion on the FDA’s ISO-13485 transition plan, its implications, and how it affects medical device companies.
Guidance on meeting ISO 13485-2016 requirements, timelines, and best practices.
Insights into regulatory expectations for SaMD, documentation, and compliance.
Understanding the changes imposed on SaMD under the new EU MDR regulation.
Guidance on supplier evaluation in compliance with FDA regulations.
Predictions and trends for medical device quality in 2024.