MEDICAL DEVICE PRODUCT DEVELOPMENT SOFTWARE

Innovate Faster Without Compromising Quality.

Greenlight Guru Product streamlines your path to market with integrated design controls and risk management—fast-track medical device development while ensuring quality and compliance.

On average, our customers experience:

35 %

Reduction in time to market

50 %

Faster design documentation

35 %

Fewer manual hours per event

144 hrs

Saved with auto-generated DHF

Calculate Your ROI

Don't Let Outdated Tools
Delay Development.

Manually compiling records, piecing together traceability, and deciphering regulations isn’t the best use of your time. With solutions designed for MedTech, refocus on what matters:
creating life-changing innovations.

Your Old System

Greenlight Guru Product

Trusted by leading medical device companies worldwide.

“Greenlight Guru was the only way we could get our team to move really quickly.”

Monti Lejia

CEO of Delta Development Team

“Our matrix was built, design reviewed, and approved in record time.”

Nick Punsalan, PMP

Principle Design Engineer of MicroAire Surgical Instruments

“Greenlight Guru's software is expensive on day one, and dirt cheap on day two.”

Daniel Powell

CEO of Spark Biomedical

“What we pay to have Greenlight Guru is repaid in efficiency.”

Clive Seymour

CEO of Canterbury Scientific

MEDTECH DESIGN CONTROL & RISK SOLUTIONS

Engineered Specifically for MedTech

Your tools should be optimized for MedTech's intricate compliance requirements. Streamline your development process and automate compliance to accelerate your timelines.

Integrated Design & Risk

Advanced design control and risk management with built-in compliance. Intuitively document device requirements and risks while you design, build traceability, and maintain living device records.

Enhanced Traceability

Reduce time spent in spreadsheets and binders. Our solution enhances traceability, teamwork, and accountability, ensuring up-to-date, accessible information.

Reduce Risk

Discover, mitigate, and prevent potential risks as early as possible while ensuring that risk management is a living process throughout the entire product lifecycle.

Built-in Compliance

Minimize noncompliance risks with validated workflows compliant with industry regulations, ensuring satisfaction for you, your quality managers, and regulators.

Platform Tools

Features that Make Innovation Efficient

Document, track, and trace all aspects of your design and development to bring high-quality devices to market faster.

Design Controls and DHF

Easily manage multi-level device requirements in your traceability matrix and generate a completed Design History File on demand.

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Risk Management

Build your risk acceptability matrix with the only cloud-based risk management solution that aligns with ISO 14971:2019. Demonstrate a risk-based approach to design with full traceability to related Design Controls.

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Flexible Review Workflows

Create and update your traceability matrices and schedule design and risk review with Part 11 compliant workflows in mere minutes — not hours or days.

Intelligent Risk Recommendations

Eliminate the guesswork with personalized insights to predict risk identify and predict the most relevant hazards and harms generated from real-world adverse event data.

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Links & Attachments

Instantly trace and retrieve design records linked to your activities enhancing visibility and access to key design and risk documentation.

Our Customers Say It Best

Accelerate Innovation,
Ensure Quality.

Discover what Greenlight Guru Product can do for you.

35 %

Reduction in time to market

50 %

Reduction in time spent on design documentation

35 %

REDUCTION IN HOURS NEEDED PER RECALL OR ADVERSE EVENT

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

MEDICAL DEVICE PRODUCT DEVELOPMENT SOFTWARE

Innovate Faster Without Compromising Quality.

Trusted by leading medical device companies worldwide.

Engineered Specifically for MedTech

Your tools should be optimized for MedTech's intricate compliance requirements. Streamline your development process and automate compliance to accelerate your timelines.

Features that Make Innovation Efficient

Document, track, and trace all aspects of your design and development to bring high-quality devices to market faster.

Our Customers Say It Best

Accelerate Innovation,
Ensure Quality.

35 %

50 %

35 %

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

MEDICAL DEVICE PRODUCT DEVELOPMENT SOFTWARE

Innovate Faster Without Compromising Quality.

Trusted by leading medical device companies worldwide.

Engineered Specifically for MedTech

Your tools should be optimized for MedTech's intricate compliance requirements. Streamline your development process and automate compliance to accelerate your timelines.

Features that Make Innovation Efficient

Document, track, and trace all aspects of your design and development to bring high-quality devices to market faster.

Our Customers Say It Best

Accelerate Innovation,Ensure Quality.

35 %

50 %

35 %

Accelerate Innovation,
Ensure Quality.