Clinical Login Support
Products

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
BestQMS-book-mockup-01

Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo
Contact Sales:
 +1 317-960-4220

#1 Medical Device QMS Software

Purpose-built solutions for medical device teams.

  • Expert backed quality management - Leverage built-in medical device expertise, audit-tested templates, and proactive support to meet regulatory expectations with confidence.

  • Scale without slowing down - Grow your team, product lines, and global reach with a scalable QMS platform that adapts to evolving business needs and compliance requirements.

  • Faster implementation, faster results - Get up and running in weeks - not months - with a pre-validated solution that delivers immediate compliance, audit readiness, and process efficiency.

Hero_G2_Spring2025_1

Contact Sales: +1 317-960-4220

See Your Personalized Demo!
Audit-2-1

Simplify Compliance. Reduce Risk. Scale with Confidence.

• Streamline compliance - Navigate FDA, ISO 13485, and EU MDR requirements effortlessly with pre-built workflows, audit-tested SOPs, and real-time traceability across your entire QMS. Stay ahead of regulatory changes without heavy customization.

• Reduce audit risk - Maintain audit-ready documentation at every stage with comprehensive document control, automated change management, and full traceability from design to post-market surveillance. Eliminate surprises when inspectors walk through your door.

• Get started quickly - Cut implementation timelines by 50% with a validated, out-of-the-box system designed for medical devices. Go live quickly with expert-led onboarding, intuitive workflows, and immediate visibility into your compliance health.

Trusted by 1000+ Medical Device companies

“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

Are You Ready to Experience the Greenlight Guru Difference?

Achieve peace of mind knowing your quality management system can stay ahead of compliance changes.

See the Demo