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Build medical devices without the
compliance chaos

Nobody knows medtech like Greenlight Guru. 1,000+ device companies trust our AI-powered platform to manage quality, product development, and clinical evidence. Spend less time on the system and more time on your device.

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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.

Key Features

Design and development

Digitally manage your DHF with built-in traceability between design inputs, outputs, verifications, and product risk controls, plus AI-powered suggestions and predictive verifiability checks.

Compliance and risk management

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

Documents and training management

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

Quality processes and events

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

Clinical data management

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

“Lets us bring safer, higher-quality devices to success while maintaining a quality culture throughout the device lifecycle.”

Dr. Gabriel Georges

Co-Founder & Chief Scientific Officer

Puzzle Medical

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Brainstorming

Generate device-specific ideas for design controls and risks so your team can start faster and avoid gaps.

AI Chat

Chat with your QMS data to summarize content, spot patterns, and answer questions without digging through records.

AI-powered global search

Search across your QMS and get direct answers with linked source references for quick validation.

Training analytics

Ask plain-language questions about training completion and get answers back as charts, directly from your data.

EXPLORE THE FEATURES

Solutions for Quality Management and
Clinical Data Collection

Deliver innovations, streamline compliance, and focus on quality.

Explore QMS

The leading clinical trial data collection toolbox built for MedTech.

Explore EDC

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.

Smart by design

Move faster with AI-powered solutions that ease the workload and help prevent compliance surprises.

“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.

See how Greenlight Guru’s MedTech Suite can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.

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QMSR is coming. Is your quality system ready?

Build medical devices without the
compliance chaos

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.