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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

Get a personalized demo of Greenlight Guru Clinical today.

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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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Design Control Software

Streamline Design Controls With Ease and Compliance

Improve the design and development process while driving collaboration and ensuring compliance. Document, track, and trace all aspects of your design control process to bring high-quality devices to market faster.

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

Design Control

Documenting Design Controls Shouldn’t Slow You Down

Documenting the design control process is complex, manual, and prone to errors. Avoid delays in product development and regulatory submissions by ensuring visibility, connectivity, and compliance.

Our multi-level traceability matrix is the most powerful and flexible way for you to manage your complex medical device products, link documents, conduct project reviews, and generate a design history file — all with a single click.

The #1 Design Control Software for
Medical Devices

Leverage Greenlight Guru Design Control Software to improve your design processes and document your design while staying compliant.

Improve Efficiency

Eliminate data silos. Create and update your traceability matrices and schedule a design review in mere minutes — not hours or days.

Obtain Traceability

Create your design control objects, link complex configurations, and attach related documents with a single click. Leave behind the days of scouring your desktop files for the data or documents you need.

Connect to Risk Management

Bring safe and effective products to market faster. Incorporate risk management while you design to mitigate issues as early as possible.

Stay Audit Ready

Provide auditors and inspectors with the signatures and objective evidence they require — on-demand.

Powerful Traceability Doesn’t Need To Be Complex

Designed specifically for MedTech professionals with simplicity and flexibility in mind.

Conduct Digital Design Reviews

Collaborate and track design reviews with Part 11 compliant workflows.

Track Research & Development Activities

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

Maintain a Living Design History File

Generate design history files and records without searching for the required documentation.

Link Design to Risk

Prioritize ISO 14971 and ensure compliance while you design your devices.

Learn More About Risk

 

 

 
Designed With Your Entire Organization in Mind

Benefits for Teams

Design Controls touch every part of your MedTech teams, so we make sure that our solution does too.

For Product Teams

Streamline design processes so you never miss a step

  • Spend more time designing and less time doing paperwork
  • Collaborate with your R&D team on verification and validation testing
  • Link all relevant documents, specifications, and design components together with a single click
Designed With Your Entire Organization in Mind

Benefits for Teams

Design Controls touch every part of your MedTech teams, so we make sure that our solution does too.

For Quality Teams

Maintain true quality, traceability, and visibility with every project

  • Bring a safe, compliant device to market with a solution built specifically for the MedTech industry
  • Easily achieve 21 CFR Part 820.30 and ISO 13485 compliance with an auto-generating, auto-updating DHF
  • Prioritize ISO 14971 and access risk connected to design controls at anytime

For Executive Teams

Support rapidly growing teams and product lines

  • Bring your products to market on time
  • Eliminate data silos that increase costs and delays
  • Prepare for large regulatory approvals and expand business ventures with confidence
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Integrate with Jira

Enable product development teams to leverage the agile functionality of Jira while maintaining traceability to Design Controls processes throughout the MedTech lifecycle.
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Software as a Medical Device (SaMD)

Industry standards require that stand-alone software components be managed separately, just like the hardware and software components of traditional medical devices. Manage both your software components and devices through their own design workflow to ensure that each component is reviewed and approved as part of the whole product.

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 Multi-level Design Control Software

Get a deep dive into our Design Control Software, ask questions, and see your multi-level design control matrix come to life.

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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

Can I link risk management to design controls in one system?

Yes. Greenlight Guru connects your risk management and design control processes in a single, purpose-built system. You’ll be able to link design controls and documents as risk control measures and maintain a dynamic, audit-ready Risk Management File at all times.

How do I ensure traceability from user needs to validation?

Greenlight Guru’s traceability matrix automatically links user needs to design inputs, outputs, verification, and validation activities. You get end-to-end visibility across the product lifecycle without the manual overhead.

How does Greenlight Guru support SaMD or multi‑component devices?

Our platform is built to handle the complexity of multi-component products and SaMD. With a multi-level design control architecture, you can easily manage interrelated hardware, firmware, and software elements while maintaining full traceability across systems.

Does the platform support Part 11‑compliant electronic signatures for design reviews?

Absolutely. Greenlight Guru includes built-in design review workflows with secure, Part 11-compliant electronic signatures so your team can approve documentation with full confidence and compliance.

Can I see it in action before buying?

Of course. You can book a call to learn how Greenlight Guru works for your team. We’ll walk you through how it simplifies compliance, speeds up development, and supports your growth.
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