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Greenlight Guru QMS

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

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

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

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Change Management Software

Discover Modern Change Management

Change is a constant. Ditch the manual, error-prone processes and collaborate in real-time on changes or issues. Leverage our fast and effective change control workflows to keep processes and documents up-to-date, while reducing risk.

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

Change-2

Conducting Changes Within Compliance Shouldn’t Be a Worry

The FDA, EU MDR, and ISO 13485 all require the documentation and management of change be done to standard. That’s why it’s critical to have a QMS that supports you in achieving regulatory compliance while you are developing your products and processes. We understand it’s a challenge to keep change both streamlined for efficiency and thorough enough to meet all the requirements.
loopMark

Consistent & Efficient Change Management

Greenlight Guru Change Management enables both small and large scale change
as you need it.

Improve Efficiency

Eliminate data silos. Manage change reviews and approvals using the same process every time.

Enhance Traceability

Connect changes across different design and quality documentation.

Remain Compliant

Obtain CE markings, gain ISO 13485 approvals, and stay compliant under FDA and EU MDR guidelines.
Collaborate Across Teams

Route and review across all your teams—document control, quality, product development, manufacturing, and operations.

Catch the Impact of Change

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

Review & Approve Change Orders

Easily capture e-signatures across your teams.

Generate Critical Change Documentation

All data captured from the change is generated into a document with documents impacted, approvers, approval date, effective date, signatures, and descriptions.

Keep on Task as a Reviewer

Reminder email correspondence generated by Greenlight Guru keeps you on track with your change orders.

HubSpot Video
HubSpot Video
HubSpot Video
Designed With Your Entire Organization in Mind

Benefits for Teams

Change can be difficult to navigate but the process should be straightforward and seamless.

For Development Teams

Collaborate on changes that impact your development and design

  • Easily review your evolving design and processes
  • Approve or reject change orders as needed
  • Evaluate and validate the need for any change
Designed With Your Entire Organization in Mind

Benefits for Teams

Change can be difficult to navigate but the process should be straightforward and seamless.

For Quality Teams

Remain compliant with every change that comes

  • Align with FDA requirements for documenting change under 21 CFR Part 82
  • Meet EU MDR requirements for documenting changes in design
  • Comply with ISO 13485

For Executive Teams

Support accelerating development

  • Cloud-based collaboration for your teams
  • Streamlined process every time
  • Predict the impact of change with Greenlight Guru Halo

See More of Our Change Management Workspace

Get a deep dive into our change process, ask questions, and see how our AI/ML recommendation engine predicts the impact of your changes.

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trusted by 800 +

medical device companies

403

hours saved on low value-added activities

1000 +

other approvals and audits passed