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Guru Difference
Product
MedTech Lifecycle Excellence Platform

The solution that powers end-to-end product lifecycle excellence from idea to commercialization to postmarket surveillance.

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State of Medical Device Industry 2022

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Customer Experience
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Change Management Software

Discover Modern Change Management

As your company grows, so do your processes. You shouldn't have to worry about how to manage change control processes as you scale. No matter how big the change, discover our easy-to-use, formalized change control solution that is efficient, consistent, and intelligent.

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800+ of the world’s leading MedTech companies trust Greenlight Guru.

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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.
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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.

See the Impact of Powerful 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.

Predict the Impact of Change

Easily access and analyze which parts of your device and process are impacted by the change.

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Keep on Task as a Reviewer

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

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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
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Get Ahead of Problems

Stop reacting to changes. Get ahead of them by predicting their impacts. Leverage unique artificial intelligence (AI) and machine learning (ML) technologies to create efficiencies and improve quality across the change management process.

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Visualize Data Like Never Before

Unlock the ability to visualize the documents and events living in your QMS. Better understand relationships and see where the impacts of change are taking place in your data networks.

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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