Medical Device Design Control Software | Greenlight Guru
1,100+ of the world's leading MedTech companies trust Greenlight Guru.
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 and development 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.
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.
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
Rating: 4.5
★★★★★
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 Therapeutics 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.
[**Get a Demo**](/content/cs/c/?cta_guid=376801ca-5bfc-41ba-ba0d-ad6cae5f68aa&signature=AAH58kEkmF61ibs3G6zoFMUxbl9gZNGRlQ&portal_id=495719&pageId=5732631570&placement_guid=11c0188f-da04-4ac2-b710-83bce071e064&click=f0f963f2-0b66-4dc8-9469-cbe7e58e5139&redirect_url=APefjpEXPWV4QVVdQk4ce4p5c8JN0vWXcQLsPF5zck-7rh33fwl80DMxiE86-sKNAVpUla3-7SyjB3ZZdDND_U4nt0n-g3WI68cI8z1gSF4W7q2NuRSQv64uEDqWvzNT6CUql3lBo-FBJOMA2X2LCsxLa8blX62jgU9n6JscZiGf97j8y4meEMk&hsutk=&canon=https%3A%2F%2Fwww.greenlight.guru%2Fdesign-control-software&ts=1789094438994 "Get a Demo"/index.html)
$125k
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.