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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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Medical Device Project Management Software

Enhance Project Management For Your Teams

Stop using complex and disjointed tools. Spend more of your time focusing on the innovation of your medical technologies for patients who need them. Uncover better project management with our Design Control Software that keeps innovation, quality, and traceability at the forefront.

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

Design Control

Data Silos Will Slow You Down

Achieving traceability using paper or other disconnected solutions can quickly become expensive and time-consuming. Your QMS should go above and beyond. With Greenlight Guru, you can drive collaboration on all ongoing project design and development activities, link any documents, conduct reviews of your projects, and generate a design history file—with a single click. Creating visibility and traceability between your quality events and project management processes will help you bring safer devices to market faster. 
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Project Management For Your Medical Devices

Leverage Greenlight Guru’s Design Control Software to manage your various device projects and document them all while staying compliant.

Improve Efficiency

No more data silos. Manage projects with ease and clarity. Create and update your project matrices and schedule a review in mere minutes, not hours or days.

Obtain Traceability

Bring your products to life in the design control project matrices, link complex configurations, and attach related documents with a single click. Gone are the days of scouring your desktop files for the data or documents you need.
Connect to Risk

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. Manage projects in a compliant workspace with your teams.

Powerful Project Management Doesn’t Need To Be Complex

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

Review Your Work

Collaborate and track design reviews with Part 11 compliant workflows.

Track Your Project

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

Generate Critical Documents

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

Link Design to Risk

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

 

 

 

 

 
Designed With Your Entire Organization in Mind

Benefits for Teams

Project management touches every part of your medical technology teams, so we make sure that our solution does too.

For Development 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

Project management touches every part of your medical technology 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 devices 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 control processes throughout the MedTech lifecycle.
Training

Software as a Medical Device

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

See More Of Our Multi-level Design Control Software

Get a deep dive into our Design Control workspace, ask questions, and see the project management capabilities woven throughout.

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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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