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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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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

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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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QMS Software for Combination Products

Reduce The Complexity of Combination Product Development

Medical devices are complex. Adding a drug or biologic component further complicates the development process and adds additional challenges. Life-changing medical devices aren’t created overnight. They require extra care and attention.

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Product Development

Time Is of the Essence

The path to commercialization for combination products is full of challenges and roadblocks. Don’t waste time with short-term, quick-fix tools. Invest in solutions made for your industry that help you succeed in the long-term. The road ahead is a hard one. Make decisions now that put you ahead of your problems and competitors later.

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

Designed for Your Industry

Pull together the power of your teams with our end-to-end MedTech solution to meet your goals across the entire product lifecycle. Watch your combination products come to life and have confidence in the work you invest in them.

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Single Source Of Truth
Development & Risk
Regulatory Compliance
Postmarket Surveillance
HubSpot Video

 

End-to-End Connectivity

Enhance team access to cross functional data and drive accountability by managing device requirements and quality efforts in a centralized workspace. Keep your teams aligned with the latest information, facilitate team communication, and streamline approvals using flexible review workflows with both internal and external stakeholders.
HubSpot Video

 

Reduce Risk and Prove Effectiveness

Combination products are inherently complex. Identify, mitigate, and prevent potential risks early and often. Integrate risk management to your product development. Proactively find and fix issues that expose you to risk throughout the product lifecycle.
HubSpot Video

 

Approach With Confidence

De Novo, 510(k), Premarket approval, CE markings, technical files—the list is never-ending. With governing authorities still developing their own regulatory processes, manufacturers have new opportunities to shape the present and future landscape. At the same time, companies developing combination medical technologies can control the unknowns and reduce barriers to compliance with our purpose-built QMS software that functions beyond general-purpose tools.


HubSpot Video

 

Get Ahead of Upcoming Challenges

Simplify and stay on top of all postmarket quality activities and processes for monitoring and measurement of output, data analysis, and product improvement. Maintain a holistic view of the lifecycle of your product throughout all areas of your system.

Built for Customers Like You

Establishing a QMS
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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare
Culture of Quality
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Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical
Impress Auditors
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Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.
https://blog.greenlight.guru/hubfs/GG22_theme-files/accents_graphics_textures_etc/testimonial-slider/testimonialSlider_default-image_rs.jpg play

Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare
https://blog.greenlight.guru/hubfs/Puzzle_Med-875x530-1.jpg play

Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical
https://blog.greenlight.guru/hubfs/C2Dx-875x530-2.jpg play

Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.

Designed for the MedTech Industry

Get a deep dive into our software, ask questions, and see your combination product lines come to life.

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