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Platform
The Greenlight Guru Platform

Solutions built for medical device teams to move faster, stay compliant, and grow with confidence.

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Quality Management

Manage quality events, training, and documentation in one place.

Document Management

Control documents, training, and change with traceability.

Quality Events

Track CAPAs, audits, and NCs with audit-ready records.

Suppliers & Operations

Qualify suppliers and manage parts with visibility.

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Product Development

Connect design, risk, and AI-powered traceability as you build.

Requirements Management

Link needs, requirements, and verification to design controls.

Software Release Management

Automate traceability from dev tools for faster releases.

Risk Management

Assess ISO 14971 risk as requirements and tests evolve.

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Clinical Evidence

Oversee studies with connected data, documents, and workflows.

Clinical Trials

Capture compliant clinical data with a validated medical EDC.

PMCF

Plan and manage PMCF aligned to EU MDR expectations.

ePRO/eCOA

Collect clinical outcome data in-person or remotely on any device.

Why Greenlight Guru
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Medical Device Expertise

Built with regulatory insight to help medtech teams move faster with confidence.

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AI, Data, Intelligence

Find issues faster and make smarter decisions with less manual work.
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Learning, Templates. Training

Tools and resources that help teams implement quickly and meet requirements.
Solutions
Customers
Partners
Company
Resources
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QMSR is coming. Is your quality system ready?

This page is your one-stop resource for understanding what’s changing, what’s at stake, and how to stay compliant.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo
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WHY GREENLIGHT GURU

The most trusted name in medtech

When you choose Greenlight Guru, you’re choosing the only team of dedicated medtech professionals who'll work tirelessly to bring you the best tools, support, and education in the industry.

Request a Demo

Trusted by 1000+ medical device companies

Unbeatable support from industry experts who know what you're going through

 
 
"Greenlight Guru feels like a true extension of our Quality team. When I need support, I’m talking to people who understand medtech, FDA expectations, and the realities of running a compliant QMS — not just software. I’m not guessing, and I’m not outsourcing expertise. We get real, practical guidance exactly when we need it."

You don’t have to settle for generic, outdated, or unproven tools

Medtech isn’t like other industries. To face the unique risks, intense pressure, and ever-changing
regulations of medtech, you need solutions built for medical device development.

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Why teams switch to Greenlight Guru

Stuck in a spreadsheet nightmare? Feeling buyer’s remorse over your last software purchase? You’re not
alone. Join the 1,000+ companies who’ve made the fast, simple switch to Greenlight Guru.



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Built for medtech teams. Backed by medtech experts.

When you choose Greenlight Guru, you get instant alignment with the latest medical device regulations and standards. From implementation onward, you’ll have the constant support and guidance of our team of industry veterans.

  • All our solutions come aligned to the appropriate FDA regulations and ISO standards
  • Our medtech focus means you stay up to date with evolving regulations
  • On-demand support from medtech professionals who’ve been in your shoes
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AI-powered workflows designed for humans

A deliberate approach to AI ensures your team gets the most out of automations that reduce busywork, uncover key connections in design and risk, and enhance search. 

  • Use AI to brainstorm requirements and verification and validation steps
  • Ask questions about your data and get trusted answers with our AI Connector
  • Automatically check new requirements for verifiability
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The leader in medtech education

Instant access to template libraries lets your team start fast, and the self-paced courses in Greenlight Guru Academy ensure you’re always learning and getting the most out of the platform.

  • Access 70+ audit-tested templates to get you started
  • Use role-based training and quizzes to keep your team sharp
  • Take self-paced courses and build your skills in the Academy

Explore the Greenlight Guru Platform

Built by medtech experts and ready for the entire product lifecycle. Whatever stage your device is at, our solutions help you move faster, stay compliant, and bring safe, high-quality devices to market.
Modern product development tools

Build faster with a compliant, traceable solution that integrates with your dev tools.

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All your clinical data,
all in one place

Build studies, collect clinical data, and manage it all in one easy-to-use system.

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Quality management made simple

An AI-powered eQMS built just for medtech and aligned with industry standards. 

Learn more
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Frequently asked questions

How long does implementation take?

The process for implementing Greenlight Guru’s QMS software will depend on the state of your current quality system. If you’re starting from scratch, Greenlight Guru’s onboarding and implementation team will help you build out a new QMS within the system with the help of 80+ audit-tested and customizable SOP templates. If you’re migrating an existing QMS, the O&I team will help you formulate a plan for migration and guide you in prioritizing the most important elements of your QMS.

Do you help migrate documents/training records?

Yes, Greenlight Guru’s implementation team helps customers migrate documents and records from their paper-based QMS or current eQMS.

Do you support Part 11?

Yes, all Greenlight Guru software is compliant with 21 CFR Part 11, the FDA’s regulation regarding electronic records and electronic signatures.

What does validation include?

Greenlight Guru’s comprehensive software validation package is based on the most recent guidance from FDA, known as Computer Software Assurance. This balanced, risk-based approach ensures our customers spend less time on validation and more time working on life-changing medical devices.

Can auditors access records?

Greenlight Guru’s software makes it easy for customers to find and access records and documentation for auditors. Our searchable systems speeds up both audit prep and the audit process itself.

What integrations/APIs exist?

Greenlight Guru’s extensive suite of flexible APIs allows you to share your critical QMS data with outside applications, and Greenlight Guru has a growing library of integrations with tools like Jira, GitHub, and SSO applications.

See the platform in action

Learn why more than 1,000 Medtech teams trust Greenlight Guru to launch and scale with confidence.

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