Enterprise QMS Software

Unleash innovation and
dominate the market

Ditch disjointed systems. Merge all your quality processes into one powerful, traceable QMS solution. Automate quality events, accelerate post-market clinical data collection, and simplify your training program.

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Is your current quality system dragging you down?
Disconnected processes and siloed data slow down product development and pose massive audit risks. With Greenlight Guru’s enterprise QMS software, you can scale without burdening your teams and increasing your compliance risk.
Your Old System
Greenlight Guru QMS
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Get efficient, connected processes at scale with Greenlight Guru

The only enterprise QMS software and EDC solution built exclusively for medical devices

Dramatically reduce the time you spend managing your QMS
  • Automate quality event processes and easily manage tasks, follow-ups, and any actions resulting from audits.
  • Say good-bye to complex customizations. Compliance with FDA regulations, EU MDR, ISO 13485:2016 and ISO 14971:2019 comes standard.
  • Your software comes pre-validated to the latest FDA guidance, so you can focus on what matters most: building life-changing medical devices.
Maintain, iterate, and develop new devices with total product lifecycle support
  • Integrated risk management and design controls lets you fast-track development while maintaining traceability. 
  • Link any item in Greenlight Guru, including change records, documents, risks, design controls, CAPAs, complaints, audits, and nonconformances.
  • Instantly trace living design records linked to your activities for enhanced visibility and access to key design and risk documentation.
Never fall behind on training with an automated, connected solution
  • Create, assign, and track individual or role-based training activities to ensure the right employees get the right training at the right time.
  • Assign training to individuals or groups, set due dates, and automate tasks to ensure completion and audit-readiness. 
  • Connect your training activities with the rest of your QMS for a fully integrated workflow in one platform.
Collect high-quality clinical data throughout the device lifecycle
  • Use software built specifically for medical device studies—no more navigating complicated and expensive pharma-centric features.
  • Never worry about compliance. Your EDC software has built-in compliance with ISO 14155:2020, EU MDR, and FDA requirements.
  • Copy and reuse forms or entire studies you’ve already built within the system to save time running numerous studies.

1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

This rolling compliance saves the time that would otherwise be needed at the end to pull together all of the documentation needed for submission, and speeds up go-to-market timing by a number of months.
Shaun Preston
Global Head of Advanced Technology & Biomedical Research, Creo Medical
Partnering with Greenlight Guru has changed the way our quality and engineering teams operate. We're more digitally connected with our dozens of supplier vendors than ever before.
Riley Van Hofwegen
CCO, Tenacore
Within the workflows, we can ensure that each and every activity will be compliant with the regulations, which is great.
Weronika Michaluk
SaMD Lead, HTD Health
I like that you can essentially build a library of forms that you can use and reuse. That makes it really easy to quickly draft a study, show it to a partner, and then fine tune it to their exact needs.
Martijn Dekkers
Clinical Research Manager, Medartis

Are You Ready to Experience the Greenlight Guru Difference?

With solutions to improve every stage of your product lifecycle and a team dedicated to supporting you, achieving excellence has never been easier.

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