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.

GREENLIGHT GURU AI

Built to take on the work that slows your team down

Greenlight Guru AI handles the repetitive, manual work that pulls your engineers out of deep work and creates delays. Our AI helps your team move faster, with confidence, at every stage of the device lifecycle.

Compliance that moves as fast as you do

The manual work in between just slows you down and introduces risk.

Get accurate answers, instantly

Asking a question shouldn’t create delays. Quickly surface information from your QMS to get the answer you need and keep your team moving.

Search

Stop digging through modules. Ask a question and get an answer from anywhere in your AI-powered QMS.

Summaries

Save time with instant summaries of documents, so the most important context is immediately clear.

Chat

Stop piecing together context across tools. Ask questions and get answers in
one place.

AI Connector

Bring the right data into the tools your team already uses for better context.

Catch problems before they're costly

Issues with your QMS don't always come to light immediately. They surface later, often during an audit. Greenlight Guru AI reduces risk as you work, for complete, defensible, documentation.

Verifiability check

Vague requirements create rework later. Catch what isn't testable before
it moves forward.

Brainstorming

Move forward faster with medtech-grounded starting points, instead of
beginning from a blank page.

Suggested links

Missing traceability creates blind spots. Create the right connections as
work is happening.

Make more time for what matters

Your time shouldn't be spent on repetitive, manual work. Greenlight Guru AI handles tasks your team hates and lets them stay focused on the work they do best.

Quiz builder

Generate training questions in one click, so your team spends time
reviewing, not writing.

Change order summarization

Writing summaries slows down updates. Draft them automatically and focus on understanding what changes.

Training analytics

Get answers to training questions on demand, without building reports or pulling
data manually.

Clinical agent

Repetitive clinical tasks pull focus from higher-value work. Complete them with simple inputs and human approval.

AI outputs your team can stand behind

In a regulated environment, every output needs a human who owns it. Greenlight Guru AI is designed for your team to review and approve anything before it's saved or acted on.

Designed to keep humans in the loop

Every AI output is a suggestion your team owns, not a decision the system makes.

Your data stays in your system

It's never used to train external models and never shared across customers.

Adopt at your own pace

Start simple and expand when you want to. Keep existing workflows in place until your team is ready.

AI built for how medtech teams actually work

For every stage

From concept to global launch.
Greenlight Guru helps your team
move faster with confidence.

For your whole team

Eliminate repetitive tasks and speed up timelines across Quality, Product Development, and Clinical.

For every pace

Start with the use cases that make sense
for your team now, then expand when
you're ready.

Frequently asked questions

What AI model does Greenlight Guru use?

We use commercially available large language models, evaluated continuously for accuracy, safety, and fit for regulated environments. We reserve the right to update models as better options emerge, without affecting your data or workflows.

Is my data secure?

Yes. Your data is isolated from all other customers, never used to train external models, and protected by the same encryption and access controls that cover the rest of your platform.

When do beta features become generally available?

GA is targeted for Q2 2026. Beta customers get early access and direct input into how features develop before broad release.

Does this work for post-market teams?

Yes. Post-market is often where manual work compounds fastest. Change orders, quality events, and training updates have to scale with the device. Greenlight Guru AI was built with that reality in mind, not retrofitted to it.

How is this different from a general-purpose AI tool?

General-purpose AI works from whatever context you give it in a prompt. Greenlight Guru AI works from your actual QMS data, such as your documents, records, and traceability and lives inside a platform built specifically for medical device teams. The answers you receive are grounded in your work, and any outputs stay inside the system that governs them.

Build smarter. Stay compliant.

Request a demo and we'll show you what Greenlight Guru AI looks like in the workflows that cost your team the most time right now.

QMSR is coming. Is your quality system ready?