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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management Supplier Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Medical Device Document Management

Compliant Document Management Meets Modern Workflows

Documents can quite literally pile up in both the MedTech and regulatory spaces. Leverage our secure, cloud-based document management system to give your team the tools they need to succeed. Finding, revising, and signing off on documents should never be a blocker. Discover what’s possible with real traceability.

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1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

Doc Man

Paperwork?
What Paperwork?

The MedTech space can be challenging, to say the least. In this ever-changing field, your processes, devices, and documents undergo multiple revisions that generate the need for new ones. It’s an endless cycle. Being able to access up-to-date versions of documents and having them on hand at a moment's notice is the key to success.

Seamless Document Management

Leverage the power of traceability with Greenlight Guru Document Management.

Eliminate Paperwork

A cloud-based, secure, end-to-end solution that houses your critical medical device documents.

Enable Collaboration

Leverage our streamlined document review and approval process and keep your teams on the same page.

Remove Silos

Data and critical documents serve as your single source of truth. No more disconnected, siloed information.

Stay Organized

Create custom attributes and views to better organize documents for yourself and your teams.

See the Impact of Automated Document Management

Designed specifically for the MedTech Industry with simplicity and flexibility in mind.

Review and Approve with Ease

Get Part 11 compliant signatures for each of your documents so you’re always audit-ready.

Add Documents to Change

Documents change over time. Let’s not complicate the process.

Link Documents Throughout

A true end-to-end software solution that enables you to link documents to your quality and development activities.

Create Custom Attributes and Views

Share your views or keep them private. All it takes is a few clicks.

 

 
Designed With Your Entire Organization in Mind

Benefits for Teams

Documentation is a necessary part of your business, so let’s make managing it simple.

For Development Teams

Collaborate on design and development documents

  • Easily access your latest design documents
  • Link documents to your design control and development activities
  • House your work instructions, process validations, SOPs, and lab test methods
Designed With Your Entire Organization in Mind

Benefits for Teams

Documentation is a necessary part of your business, so let’s make managing it simple.

For Quality Teams

Ensure compliance is embedded throughout

  • Align with Part 11 CFR Part 820 requirements
  • Link documents to key quality processes
  • Comply with ISO 13485

For Executives

Support development of your teams and business

  • Cloud-based collaboration for your teams
  • Streamlined process every time
  • Visualize where and how your documents relate to the rest of your ecosystem
Doc Man-2-1

Unlock Traceability For Quality and Development

Link documents to your Greenlight Guru CAPA, Nonconformance, and Audit workspaces seamlessly. As you conduct your verification and validation testing, you can also link documents to your design and development work.

What Our Customers Are Saying

★ ★ ★ ★ ★

Read In-Depth Reviews Here.

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate all of our audits this year”
Amanda Feddersen
QA Manager, Monitored Therapuetics Inc.
“There are a lot of dependencies that occur in every part of a quality system. Greenlight Guru is a fantastic software because it addresses each one.”
Morris Sherwood
Regulatory Compliance, Zyris
“Greenlight Guru's Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so much more effective.”
Crystal Womack
Quality Manager, Avenda House

See More of Our Document Management Workspace

Get a deep dive into our solution and experience traceability like never before.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

Frequently Asked Questions

What’s the difference between a regular DMS and one made for medical devices?

Traditional document management systems aren’t built for the complex compliance needs of medical device companies. Greenlight Guru’s document management software is purpose-built to meet FDA and ISO standards, giving you traceability, validation, and audit-ready control out of the box.

What features should medical device companies look for in a document management system?

You need more than just storage. Look for role-based permissions, version control, automated review and approval workflows, audit trails, and built-in support for 21 CFR Part 11 and ISO 13485 requirements.

What are the benefits of using cloud-based document control software for medtech?

A cloud-based system like Greenlight Guru gives your team secure, real-time access to controlled documents from anywhere. It helps reduce manual errors, streamlines collaboration, and speeds up audit readiness across global teams.

Is there a built-in review and approval workflow for controlled documents?

Yes. Greenlight Guru includes built-in workflows for document review and approval, complete with Part 11-compliant electronic signatures. You can route documents automatically to the right team members and maintain a clear record of every decision.

Does Greenlight Guru support metadata tagging and advanced search?

Definitely. Documents can be tagged and organized using metadata, making them easy to find with powerful search and filter tools. No more digging through shared folders or outdated versions.

How do I migrate documents into a compliant system like Greenlight Guru?

Our team helps guide the entire document migration process to ensure a smooth and compliant transition. You will get expert support to organize, validate, and map your existing content into the system the right way.
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