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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

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 Case Report Forms (eCRF) 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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Engineering Change Management Software

Ensure Accuracy and Speed with Seamless Change Management

Well-executed change management is critical for the development and commercialization of all medical devices. With Greenlight Guru’s end-to-end system, your team can efficiently review, collaborate on, and approve design changes to manage device updates–all while easily tracing through the BOMs, quality actions, and design history file so the best decisions can be made.

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1,000+ of the world’s leading MedTech companies trust Greenlight Guru.

Change

Don’t Lose Track of Changes

When it comes to managing continuous product development, paper and spreadsheets are inadequate. Whether you are in the beginning stages of designing and validating your medical device or keeping up with changes made postmarket, creating, sharing, and approving changes shouldn't stand in your way. Run your change process in Greenlight Guru and have all the information you need to make the right decisions.

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Documenting All Changes
Made Easy

Whether you are building and making changes to your BOM or documenting changes to your design controls, Greenlight Guru provides the tools necessary to create and maintain successful medical devices.

Experience Traceability

See your engineering change management activities connected throughout the Greenlight Guru ecosystem. Link to the critical quality events related to design changes and close the gap between design history file and device master record by connecting back to your design controls.
Streamline the Process

With Greenlight Guru’s easy to follow, step-by-step, change process, teams gain back invaluable time. A consistent known path removes barriers that often occur with undocumented or poorly supported processes and team changes.
Collaborate Effectively

Bring the right team together–wherever and whenever they work from–to review changes and provide approvals aligned with ISO 13485.

Reduce Mistakes

Eliminate the inevitable mistakes of omission, duplication, confusion, and poor data entry that come from working with paper, spreadsheets, email, and shared drives.

Product Management Integrated With Your QMS

Designed specifically for the MedTech Industry with your product process needs in mind.

Document Changes Made to Your BOM Items

Route for approvals within the Greenlight Guru Products software.

Design Control Matrices Change as You Grow

It’s no easy feat to ensure all your designs fulfill user needs, and it’s nearly impossible to get right the first time around. Greenlight Guru makes it easier for your design and development teams to evolve and improve your technologies.

Route Consistently Throughout Our Software

Efficient and familiar processes will save your team time so you can focus on innovating.
Designed With Your Entire Organization in Mind

Benefits for Teams

Continuous product development and management touch every part of your medical device teams, so we make sure that our solution does too.

For Product Development Teams

Streamline design and development no matter your stage

  • Spend more time developing your medical devices and less time on paperwork
  • Collaborate with your R&D teams on changes made
  • Ensure success of your medical devices
Designed With Your Entire Organization in Mind

Benefits for Teams

Continuous product development and management touch every part of your medical device teams, so we make sure that our solution does too.

For Quality Teams

Maintain visibility and true quality with every project

  • Bring safe and compliant products to market
  • Capture e-signatures aligned with ISO 13485
  • Ensure the latest designs are documented throughout your QMS

For Executive Teams

Support growing teams and product lines

  • Bring safe, life-changing medical devices to market
  • Eliminate data silos between product development and quality processes
  • Save team time and dollars
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Collaborate with Suppliers

Having the power of engineering change management at your fingertips is critical when communicating with suppliers. As the recipe for your medical device changes over time, it can be relayed to your suppliers. For example, maybe you don’t need a certain material anymore or maybe your supplier specifications have changed. Either way, Greenlight Guru gives you the power to document those changes so everyone on your team has the most up-to-date information.

See the Impacts of Engineering Change Management

Get a deep dive into product development best practices and see how you can level up your efforts.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities
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