CONTACT US AT 317-960-4220




About Greenlight Guru

green check Our Premarket Quality Management Software helps you set the right foundation to bring safer, high-quality medical devices to market faster.
green check Our Postmarket Quality Management Software provides visibility that decreases risk so you can advance the success of your medical devices.
green check Our Expert Quality Management Partners help you establish and advance a quality culture throughout your entire device lifecycle.


risk software on screen - slide-in


All-in-one, easy-to-use, Modern QMS that simplifies regulatory compliance and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance.

  • Automate design control and risk activities
  • Follow FDA & ISO best practices
  • Achieve end-to-end traceability
  • Enhance team collaboration
  • Streamline submission and device clearance
  • $125,000 saved on average cost estimated per project
  • Improved culture during project cycle
  • 2.5 months faster to market



  • 402 hours saved on low value-added activities
  • Single source of truth for all quality processes
  • Better audit readiness



green-quotes Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA Submission. 


Ryan Nolan
Co-Founder & VP of Clinical Operations PhotoniCare







green-quotes We wanted a QMS that was robust enough to grow with us, but simple enough to get us started.  


kevin mcleod 
ceo at c2dx, inc




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