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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Training Management CAPA Management

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

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Built for MedTech.
Trusted by MedTech.

Greenlight Guru brings modern QMS and EDC software to medical device companies helping improve speed and efficiency while reducing risk.

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1,000+ of the world's leading MedTech companies trust Greenlight Guru.

MedTech Teams are Drowning in Disconnected Systems

Relying on generic, disconnected tools distracts your focus and leads to increased risk.
Don't settle for single-point solutions. Our platform powers end-to-end product lifecycle excellence from idea to commercialization to postmarket surveillance.

Quality Management (QMS)

Enable a culture of quality with a connected ecosystem that is collaborative, organized, and traceable. 

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Product Development

Bring innovations to life with an integrated solution that accelerates your delivery of high-quality devices.

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Clinical Electronic Data Capture (EDC)

Simplify compliance with continuous, cost-effective clinical evaluation and trial data management.

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Academy

Accelerate your learning and proficiency in current industry best practices. Build your teams' key competencies with practical lessons and comprehensive certifications.

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The Old Way

Single-point solutions used in MedTech have failed to deliver a seamless and compliant source of truth for team collaboration, tracking progress, and making better business decisions.

75 % of medical device companies fail
$ 100 B in adverse quality costs every year
5 + years avg to FDA 510(k) clearance and CE mark

The New Way

Greenlight Guru integrates cross-functional teams, processes, and data at every stage of the product lifecycle, giving you a 360 and predictive view of gaps and impact.