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

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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.

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Data collection and management designed for MedTech clinical trials.

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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.

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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.

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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.

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Trusted by 1000+ Medical Device companies

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

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Maximize Efficiency

Drive efficiency across the entire device lifecycle

Managing the device lifecycle takes exceptional organization and collaboration. Greenlight Guru provides solutions for all your critical operations, from Quality and Product Development to Clinical Affairs.

Track quality events, quickly find documents and records, and always maintain traceability.

 For QA / RA teams

Accelerate product development with powerful design control workflows connected directly to risk.

 For Product Development teams

Collect high-quality, compliant clinical data and manage it all in a single system.

 For Clinical teams
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Simplify Compliance

Be confident in
your compliance

The medical device industry is unique, and so are the challenges of its ever-evolving regulations and standards. That’s why we built Greenlight Guru specifically for medical device companies—to focus on keeping you compliant and audit-ready at all times.

  • Ensure compliance with audit-tested templates and workflows that adhere to regulatory requirements.

  • Stay audit-ready at all times with a single, searchable system that maintains traceability.

  • Ensure ISO-14155 compliant clinical studies with all your clinical data in a single platform.

  • Keep your team compliant with role-based training, quizzing, and completion tracking.

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SCALE WITH CONFIDENCE

Support for your next
stage of growth

Growth adds layers of complexity—more markets, products, and people complicate timelines and strain already busy teams. Greenlight Guru’s expert-backed solutions are designed to support your team now and in the future as you scale.

  • Simplify operations with dedicated workspaces for supplier management and training.

  • Collect clinical data at any stage of your device from pre-market pivotal studies to post-market clinical follow-up.

  • Nip problems in the bud with compliant workflows for CAPA, nonconformances, and complaints.

  • Get guidance and support from experienced medical device professionals whenever you need it.

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Launch With Confidence

Accelerate submission timelines

With the wrong tools, the timeline between design and product launch can drag out endlessly, filled with manual updates, document hunts, and miscommunication. With Greenlight Guru, your product and quality teams work in the same system, encouraging collaboration, simplifying compliance, and eliminating preventable delays.

  • Enhance collaboration with a design controls workspace that’s fully connected to the rest of your QMS.

  • Expedite review and approvals with a single system for planning and carrying out design reviews.

  • Build your own clinical investigations and obtain any clinical evidence you need for market access.

  • Automate time-consuming tasks like updating your DHF and searching for records.

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Solutions for Quality Management and
Clinical Data Collection

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Deliver innovations, streamline compliance, and focus on quality.
Explore QMS
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The leading clinical trial data collection toolbox built for MedTech.
Explore EDC
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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.

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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