$100 FREE TOOL
Pre-Audit Checklist For Medical Devices
Audits are vital to maintaining regulatory compliance, and even minor oversights can lead to costly findings.
This trusted, itemized checklist ensures you can confidently review every critical element of your Quality Management System (QMS) and address potential gaps before they become problems.
From marketing data to open change controls, this checklist ensures no critical detail is missed. Designed for medical device companies with a QMS in place for at least a month, it helps you identify gaps and confidently prepare for both internal and external audits, including FDA and ISO reviews.
This proven checklist is originally priced at $100, but Rook Quality Systems and our trusted partner, Greenlight Guru, are offering it to you for free!
This Pre-Audit Checklist Will Help You:
- Organize Your Audit Preparation: Structured and itemized, it ensures every QMS element is addressed.
- Ensure a Comprehensive QMS Review: Designed for established QMS systems, it highlights gaps before they become audit findings.
- Complete Outstanding Tasks: Track open items, finalize records, and update SOPs to avoid surprises.
- Strengthen Internal Audit Processes: Pinpoint areas for improvement to ensure your QMS is ready before an external audit.
- Gain Confidence for External Audits: Whether preparing for an FDA or ISO audit, this checklist reduces risks and increases readiness.
What’s Included With This Tool:
- A downloadable Microsoft Word file that is clear, customizable, and easy-to-use.
- A full checklist covering essential QMS areas, from marketing data to change controls.
Download your free copy of this Pre-Audit Checklist today and ensure your QMS is fully audit-ready.
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About Rook Quality Systems
Rook Quality Systems is a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems. For over a decade, Rook has specialized in Quality and Regulatory strategies for its medical device clientele.
At Rook, our mission is to enable clients to implement compliant Quality Management Systems (QMS) so that they can efficiently produce effective and reliable medical devices. We build these QMS so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.
Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook’s team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs).
Learn more about Rook’s medical device Quality and Regulatory support.
About Greenlight Guru
Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies.
The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.
Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.
Learn more about Greenlight Guru’s purpose-built for MedTech eQMS platform.
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