Modern solutions
for the entire medical device lifecycle

Greenlight Guru combines intuitive software with deep industry expertise to help your medical device company grow efficiently and stay audit-ready at all times.

Trusted by 1000+ Medical Device companies

Greenlight Guru helps medical device companies stay organized and compliant throughout the product lifecycle—iterating, growing, and improving patient outcomes.

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Key Features

Design and development

Digitally manage your DHF with built-in traceability between design inputs, outputs, verifications, and product risk controls.

Design and development
Compliance and risk management

Track and manage operational risk across your QMS – from regulatory requirements to audit readiness and CAPA trends.

Compliance and risk management
Documents and training management

Control documents, changes, and training in one place – with automated routing, audit trails, and role-based access.

Documents and training management
Quality processes and events

Log, track, and resolve quality events in a connected system that links CAPAs, training, and documentation.

Quality processes and events
Clinical data management

Capture compliant, audit-ready clinical data across every phase of your study - from first-in-human to post-market.

Clinical data management
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“Lets us bring safer, higher-quality devices to success while maintaining a quality culture throughout the device lifecycle.”
Dr-Gabriel-Georges

Dr. Gabriel Georges

Co-Founder & Chief Scientific Officer

Puzzle Medical

Solutions for Quality Management and
Clinical Data Collection

What's New
2025 Medical Device Industry Report
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Why Greenlight Guru?

Made for medical devices

Get software built specifically for your business needs, backed by experienced industry experts.

Guided implementation

Measure time-to-value in weeks—not months or years—as work through your personalized implementation plan.

Built for growth

Whether you’re developing your first device or managing a portfolio on the market, Greenlight Guru is designed to support you now and in the future.

Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate all of our audits this year
Amanda Feddersen
QA Manager, Monitored Therapuetics Inc.
There’s a lot of dependencies that occur in every part of a quality system. Greenlight Guru is a fantastic software because it addresses each one.
Morris Sherwood
Regulatory Compliance, Zyris
If I were to quantify it, it's days of time saved. What used to take six weeks, now takes a much shorter time period. The cost of Greenlight Guru is repaid in efficiency.
Clive Seymour
CEO of Canterbury Scientific
Greenlight Guru's Design Controls module is powerful and the traceability present across the entire QMS in my favorite part about the software. It makes remote collaboration so much more effective.
Crystal Womack
Quality Manager, Avenda House

Scale faster, improve efficiency, and mitigate risk with software that goes beyond compliance.

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