Medical Device Product Development Software

Automate the Tasks That Delay Development.

Turn hours into clicks — whether you're managing design control matrices, change orders, design reviews, 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.

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.

Nick Punsalan, PMP

Principle Mechanical Design Engineer | MicroAire Surgical Instruments

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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Design Controls DHF

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.

Design Review Plan

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.

End-to-end Traceability

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.

Risk Management

Risk Management

Mitigate and Manage Risks Proactively

Set up your matrix, document hazards and patient harms, and auto-calculate probabilities to mitigate risks early. Foster collaboration within your quality ecosystem to ensure compliance and efficient product development.

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