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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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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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Contact Sales:
 +1 317-960-4220

QMS built for agile SiMD & SaMD teams

Quality management, finally at engineering speed. Move faster. Stay compliant.

  • Engineering-first workflows - Connect your dev tools, auto-link test data and risks, and build your DHF in the background.

  • Get started faster - No clunky onboarding. Intuitive UI and API-based setup means you're running in a day, not weeks. 

  • Automated compliance and cybersecurity - Auto-generate audit-ready records, track SBOM vulnerabilities, and meet FDA cybersecurity guidance with ease. 

 

Contact Sales: +1 317-960-4220

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start fast. scale smart.

Purpose-built for software-driven devices

  • Built-in IEC 62304 alignment

  • Full design control traceability

  • Rapid iteration + validation support

  • Real-time risk and post-market management

Trusted by leading MedTech innovators

“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