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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 Supplier 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 Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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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.

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Medical Device Product Development Software

Automate the Tasks That Delay Development.

Turn hours into clicks — whether you're managing design control matrices, change orders, design reviews, or your DHF. With Greenlight Guru, getting to market faster comes naturally.

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On average, customers experience:
35 %
Reduction in time to market
50 %
Reduction in time spent on
development and design
documentation
35 %
Reduction in manual hours needed
per recall or adverse event
144 hours
Saved with automated DHF
Calculate Your ROI

The trusted product development platform for MedTech companies worldwide.

Product-1

You Can’t Make Progress When Your Focus Is Scattered.

Manual, repetitive, and low-value tasks create a labor-intensive drag on product development. Greenlight Guru puts them on autopilot. Accelerate your timelines while creating compliant and organized records for more successful regulatory submissions and ISO certifications. 

Nick Punsalan, PMP

Our matrix was built, design reviewed, and approved in record time. Things that normally take us months took weeks, things that took weeks took days. Some things now are even taking mere hours to complete.

Connect Your Teams, Your Data, and Your Design.

Collaborate while you design.

Your product and quality teams are connected, making it easier and more efficient to develop safe and compliant products.

Trace and retrieve records on demand.

No more hunting through binders and desktop files. Full traceability puts you in control of your data.

Speed up reviews and approvals.

Team members can plan, send, and collaborate on design reviews through a single interface.

Spend More Time on the Tasks That Get You to Market Faster.

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Design Controls DHF
Design Controls & DHF

Develop Without Bottlenecks

Eliminate data silos, achieve compliance, and prevent delayed timelines. Document device requirements and simplify traceability while you iterate through your design - with a DHF that generates and updates automatically. 
Design Review Plan
Design Reviews

Make Innovation Efficient

Streamline, document, and approve design reviews without your momentum grinding to a halt. Collaboration is effortless with an intuitive interface and full visibility of design matrices.
End-to-end Traceability
Traceability

Track and Retrieve Records Instantly

Whether you're in quality or development, the data you need is at your fingertips. Easily track data through quality events, compliance, design controls, and risk matrices — no matter your device's complexity. 
Risk Management
Risk Management

Mitigate and Manage Risks Proactively

Set up your matrix, document hazards and patient harms, and auto-calculate probabilities to mitigate risks early. Foster collaboration within your quality ecosystem to ensure compliance and efficient product development.

What Our Customers Are Saying

★ ★ ★ ★ ★

Read In-Depth Reviews Here.

“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 are 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
“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.”
Crystal Womack
Quality Manager, Avenda House

Go From Ideation to Commercialization in Less Time, With Less Work.

We'll show you how.

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50 %

Reduction in time spent on development and design documentation

35 %

Reduction in time to market

144

Hours Saved with automated DHF

Frequently Asked Questions

What tools reduce manual effort in medical device development?

Greenlight Guru streamlines product development by eliminating the need for spreadsheets and disconnected tools. Automated workflows, built-in templates, and centralized data help teams work faster and with fewer errors, so they can focus on building safer, more effective devices.

Can I build and manage multi-level BOMs while tracking design history automatically?

Yes. Greenlight Guru allows you to organize complex product structures with multi-level bills of materials while your design history file is updated automatically in the background, ensuring nothing gets missed as your device evolves.

Does Greenlight Guru provide end‑to‑end traceability from risk to design and quality activities?

With Greenlight Guru, every element of your product development is connected. You can trace the full lifecycle of a requirement, from user need to design input, design output, verification, and validation, along with associated risk management and quality records—without manual tracking.

How does Greenlight Guru support FDA and ISO requirements during product development?

Greenlight Guru is designed to help you meet regulatory expectations from day one. The platform supports structured documentation, controlled design processes, and validated workflows that align with 21 CFR Part 820 and ISO 13485 standards.

What sets Greenlight Guru apart from other platforms?

Unlike generic project or document tools, Greenlight Guru is built exclusively for the medtech industry. It brings product, quality, and regulatory teams into one purpose-built system that shortens development cycles, reduces risk, and supports global compliance from concept to launch.
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