Greenlight Guru | The #1 QMS for Medical Devices
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Trusted by 1000+ Medical Device companies
Explore the Greenlight Guru Platform
Built exclusively for medtech companies, so your team stays compliant, confident, and ready for scrutiny at every stage of the device lifecycle.
Quality Management System
Your quality system stays current and audit-ready without your team manually holding it together.
Product Development
Design controls and traceability that build your compliance record as your team works.
Electronic Data Capture
Run studies, collect data, and own your clinical evidence in one system built for device manufacturers.
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.
AI that removes the friction slowing your team down
Help your team find answers faster, understand context, and spend less time on manual work without changing how they operate.
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.
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.
Testimonials
Amanda Feddersen
QA Manager, Monitored Therapuetics Inc.
“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.”Morris Sherwood
Regulatory Compliance, Zyris
“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.”Clive Seymour
CEO of Canterbury Scientific
“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.”Crystal Womack
Quality Manager, Avenda House
“Greenlight Guru's Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so much more effective.”
Scale faster, improve efficiency, and mitigate risk with software that goes beyond compliance.
See how the Greenlight Guru Platform can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.