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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 Risk Solutions 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

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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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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Medical Device Product Development Software

Automate the Tasks That Delay Development.

Turn hours into clicks — whether you're managing design control matrices, change orders, BOMs, or your DHF. With Greenlight Guru, getting to market faster comes naturally.

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On average, customers experience:
35 %
Reduction in time to market
50 %
Reduction in time spent on
development and design
documentation
35 %
Reduction in manual hours needed
per recall or adverse event
144 hours
Saved with automated DHF
Calculate Your ROI

The trusted product development platform for MedTech companies worldwide.

Product-1

You Can’t Make Progress When Your Focus Is Scattered.

Manual, repetitive, and low-value tasks create a labor-intensive drag on product development. Greenlight Guru puts them on autopilot. Accelerate your timelines while creating compliant and organized records for more successful regulatory submissions and ISO certifications. 

Nick Punsalan, PMP

Our matrix was built, design reviewed, and approved in record time. Things that normally take us months took weeks, things that took weeks took days. Some things now are even taking mere hours to complete.

Connect Your Teams, Your Data, and Your Design.

Collaborate while you design.

Your product and quality teams are connected, making it easier and more efficient to develop safe and compliant products.
Trace and retrieve records on demand.

No more hunting through binders and desktop files. Full traceability puts you in control of your data.
Speed up reviews and approvals.

Team members can plan, send, and collaborate on design reviews through a single interface.

Spend More Time on the Tasks That Get You to Market Faster.

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HubSpot Video
Design Controls & DHF

Develop Without Bottlenecks

Eliminate data silos, achieve compliance, and prevent delayed timelines. Document device requirements and simplify traceability while you iterate through your design - with a DHF that generates and updates automatically. 
HubSpot Video

 

Design Reviews

Make Innovation Efficient

Streamline, document, and approve design reviews without your momentum grinding to a halt. Collaboration is effortless with an intuitive interface and full visibility of design matrices.
HubSpot Video

 

Traceability

Track and Retrieve Records Instantly

Whether you're in quality or development, the data you need is at your fingertips. Easily track data through quality events, compliance, design controls, and risk matrices — no matter your device's complexity. 
HubSpot Video

 

BOMs & Product Management

Be in Control of Your BOMs.

Create multi-level Bills of Materials, organize by product families, and manage items at the component level. Your BOMs connect to the rest of your quality ecosystem, ensuring compliance and efficient product management. 

Go From Ideation to Commercialization in Less Time, With Less Work.

We'll show you how.

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50 %

Reduction in time spent on development and design documentation

35 %

Reduction in time to market

144

Hours Saved with automated DHF