Complaint Template Bundle | Greenlight Guru + RQS

$199 FREE TOOL

Complaint Log + Form Template Bundle

Are you struggling to establish a complaint-handling process that complies with FDA regulations? Our free Complaint Template Bundle can help!

These ready-to-use templates are specifically designed for medical device companies, including LDT/IVD manufacturers, to meet FDA's complaint handling requirements and ensure patient safety.

What’s inside this free bundle:

Complaint Log Template: This customizable tool has been built according to FDA's complaint handling requirements and is structured to capture and track all necessary details, giving you peace of mind and helping you avoid compliance gaps.
Complaint Form Template: This easy-to-use form simplifies the complaint submission process and ensures that all relevant information is captured efficiently and in a compliant format, helping you keep records accurate and audit-ready.

This powerful bundle is originally priced at $199, but is being offered to you for free by Greenlight Guru and our trusted partner Rook Quality Systems.

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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).

Visit their website to learn more.

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.

Visit our homepage to learn more.