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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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Greenlight Guru for QA & RA Professionals

Ensure your company delivers compliant, high-quality devices with our industry-specific end-to-end quality management system. With Greenlight Guru, you’ll be able to digitally track and manage quality events, ensure your team's documentation is audit-ready, and drive traceability throughout your processes.

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Nonconformance

Say Goodbye to Disconnected QA and RA Processes

From trying to keep up with evolving compliance requirements to simply not having enough time, the QA and RA process can be a headache — but it doesn't have to be. When you're working with Greenlight Guru, you’ll never have to fear that you’re missing something. You’ll be able to navigate your QMS system with ease, gain visibility into historically-siloed data, provide accurate risk analyses, and keep your team’s go-to-market plan on track. See how a QMS designed specifically for MedTech QA professionals makes your life easier — you deserve it.

Why QA & RA Professionals Love Greenlight Guru

Enable True Quality
Democratized Approach
Always Audit Ready
Save the Day
Learn from the Best
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Turn Quality Into An Asset

Enable a culture of quality by managing quality events like CAPA, Customer Feedback, and Audits in Workspaces with 21 CFR Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders.

Implement True Quality
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Break Down Silos To Unite Your Teams

We provide a democratized approach to product development, helping organizations share information laterally across departments throughout the product life cycle. Our approach also breaks down organizational silos that restrict your department’s ability to collaborate effectively with other teams.

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Hit Tight Deadlines

Quickly organize and submit for FDA approvals or audits, ensuring no delays on go to market deadlines and satisfying both leadership and product team demands.

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Be An MVP For Your Organization

Free your team to do more real work by consistently helping your company clear compliance milestones while creating a high-quality product that meets user needs.

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Leverage educational content from QA & RA experts

With Greenlight Guru Academy, you’ll learn practical lessons and be able to access comprehensive certifications applicable to the entire MedTech industry.

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

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.
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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
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.

Simplify Quality in a Rapidly Changing Regulatory Environment

Adapt and overcome your toughest QA and RA challenges with Greenlight Guru.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities