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 Supplier Management

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

Request a Demo

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

Electronic Data Capture (EDC) 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
logo-github python-logo-generic travis-ci logo-playwright-vertical apache_maven-ar21 yarnpkg-ar21 logo-azure logo-aws-small-v3 logo-pytest-small logo-npm-small

Product Development and QMS software for SiMD/SaMD

The perfect balance of speed and compliance

Build and iterate faster while staying on the right side of regulations with Greenlight Guru’s solutions for software-enabled devices.

Get a Demo

Legacy solutions aren’t built for SiMD/SaMD

Most QMS software can't keep up with iterative, agile development. Greenlight Guru gives engineering-led teams structure without constraint.

Lightweight by design

Intuitive UI and integrations with your favorite dev tools mean you get started in hours, not weeks or months. 

Built for flexibility

Run design reviews, link risk management, and track every change—without changing your team’s current workflows.

Moves as fast as you do

Let your team work at the speed they’re used to, with built-in AI that auto-links requirements, tests, and risks.
Automated compliance documentation

Automated compliance documentation

Easily implement engineering best practices to stay compliant with IEC 62304 and other regulatory standards. Our solution auto-generates audit-ready records in the background as you code, linking test data and design changes directly to your DHF for full traceability.
Jira Issue Tracking

Works with the tools you love

Greenlight Guru connects with the tools you already use and pulls test data, protocols, and results into a living DHF. Set up in minutes with just a few lines of code—no process change required.
Built-in cybersecurity compliance

Built-in cybersecurity compliance

Managing SBOMs manually leads to gaps and audit risk. Built-in tools help you meet FDA requirements by scanning components, tracking vulnerabilities, and documenting cybersecurity risk through an FMEA-driven workflow—all in one system.
Insight into vulnerabilities

Insight into vulnerabilities

Automatically scan SBOMs to identify known vulnerabilities in SOUP and OTS components. Understand exposure in real time and assess risk before it impacts product safety, security, or compliance.
End-to-end traceability

Maintain end-to-end traceability as you work

When documentation builds in the background, you build faster. Link design inputs to test results, connect risks to controls, and keep everything traceable without leaving your engineering tools. Nothing gets lost, and your DHF stays inspection-ready.

Why Greenlight Guru

Built for software. Backed by experts.

Get a QMS that moves as fast as your team does—backed by industry experts who’ll guide you on the way to market.

Onboard quickly, scale easily

Implement in hours with bulk import/export. Use only the features you need right now, and add functionality as you grow.

Configurability meets compliance

Customize templates, phases, and fields to match your team’s processes while leaving validation to us.

Get a Demo

Why SiMD/SaMD teams are moving to Greenlight Guru

“This is the future for Software as a Medical Device documentation.”
Quality Team Lead
SaMD company
“Greenlight Guru helped us avoid a $200K validation project with [legacy tool].”
Quality Team Lead
SaMD company
“So easy to set up - seamless integration. We were able to get our documentation ready very, very quickly.”
Engineer
SaMD company
“Our software team has been able to move much faster because of this tooling, and we've been able to unify the QMS and Design Documentation for both hardware and software teams.”
CEO
SiMD company
“I just want to say, the engineering team really thinks this is the future for Software as a Medical Device documentation.”
Quality Team Lead
SaMD company
“So easy to set up - seamless integration. We were able to get our documentation ready very, very quickly.”
Engineer
SaMD company
“Our software team has been able to move much faster because of this tooling, and we've been able to unify the QMS and Design Documentation for both hardware and software teams.”
CEO
SiMD company
Search Results for:
    Load More Results