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Guru Difference
Product
MedTech Lifecycle Excellence Platform

The solution that powers end-to-end product lifecycle excellence from idea to commercialization to postmarket surveillance.

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QMS Software

An Easy-to-Use QMS

Who knew that'd be revolutionary?

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800+ Leading Medical Device Companies Implement Their Quality Culture Using Our QMS Software

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The Capabilities You Want With The Insights
You Need

The only Quality Management Software designed to help MedTech teams deliver innovations to market, streamline compliance, and focus on quality — all in one end-to-end platform.
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Yes, It’s Possible To Love Your QMS

For MedTech teams, friction around quality and compliance is the ultimate foe. Stitching together single-point solutions and addressing their gaps slows you down and stalls your growth. Greenlight Guru eliminates friction by bringing together the right insights and capabilities to keep your data connected in an end-to-end, visual QMS platform that connects your team. Now you are freed up to focus on what really matters—improving quality of life.

Achieve End-to-End Traceability

Easily trace CAPAs all the way back to your design controls so you can focus on accelerating your business.
Automate Quality Processes

Drive your processes step-by-step with custom workflow templates built into your QMS.
Follow FDA/ISO Best Practices

The only QMS software with the latest FDA and ISO best practices specific to MedTech companies built into every feature.
Visualize Connections Within Your QMS

Better comprehend and communicate relationships while keeping track of the details and trending quality information.

The Only QMS Platform Built for MedTech Teams

Greenlight Guru is the only modern, purpose-built solution to give MedTech companies an end-to-end system to manage the lifecycle of their product — all in one place.

Easily Access Up-to-Date Documents

Work on the most current version and save time with Part 11 compliant e-signatures, flexible review & approval workflows, and revision control.

Manage Change

Maintain Device Traceability

Create detailed design control objects, link complex configurations, and attach documents with one click.

Modern Design Controls

Streamline Product Development

Integrate quality and risk management into your design and development processes from the start.

Get Ahead of Risk

Manage Quality Processes Systematically

Remain compliant and manage Nonconformances, Audits, and CAPAs  throughout your product lifecycle.

Always Audit Ready

Enhance Team Collaboration

Communicate where your team works. Avoid unnecessary meetings and emails by collaborating across apps.

Ensure Training Compliance

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Your End-to-End Platform

Enable a Culture of True Quality

A Connected Quality Platform Built for MedTech Companies

For Product Teams

Do more value-added engineering work and less compliance paperwork.

  • Streamline the management of device requirements, risk, design reviews, and documentation
  • Device submissions are expedited and audit readiness is inherent in the software
  • Easily demonstrate traceability between Design Controls and Risk with fully integrated risk management
  • Drive accountability and collaboration across distributed teams to assure key development milestones are met
  • Enable a renewed focus on developing better medical devices by focusing on value-added tasks
Your End-to-End Platform

Enable a Culture of True Quality

A Connected Quality Platform Built for MedTech Companies

For Quality Teams

A connected quality ecosystem where every record of your QMS is organized, centralized, and traceable.

  • Simplify quality in a rapidly changing regulatory environment
  • Track and manage quality events and associated follow-up tasks digitally
  • Capture usable quality metrics in real-time
  • Assure your team's documentation is audit-ready in real-time
  • Drive traceability throughout your quality, design, and risk processes

For Leaders

Empower your team with a software platform that accelerates device clearance timelines.

  • Accelerate product development efforts and improve the quality of regulatory submissions
  • Leverage quality as a strategic advantage to protect your brand and impact the top and bottom lines
  • Grow faster with a quality system that allows you to scale and navigate different international markets
  • Achieve peace of mind knowing your quality system can stay ahead of compliance changes
  • Proactively identify and reduce risk

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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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities