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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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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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Greenlight Guru for Startups

We were once a startup, so we have a soft spot for others working hard to succeed in their early days as a MedTech company. We’ve been there, done that, and are ready to help you grow to commercialization and beyond.

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

Premarket Quality Management Software

Bring Safer, Better Medical Devices to Market Faster

Automatically Maintain Full Traceability
  • Update your traceability matrices in minutes, not hours or days. Then, easily export well-formatted records on-demand.
  • Create detailed design control objects, link complex configurations, and attach documents with a single click.
  • Generate design history files without searching for the required documentation.

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Easily Access Up-to-Date Documents
  • Save time with Part 11 compliant e-signatures, flexible review and approval workflows, revision control and linking.
  • Know your team is always working from the most current version of a document.
  • Find documentation during audits and inspections without chasing down stakeholders and files.

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Gain New Visibility and Mitigate Risk
  • The only cloud-based risk management solution that aligns with ISO 14971:2019.
  • Visualize relationships between requirements, risks, and verification tests.
  • Keep your risk management file up to date and avoid costly rework by mitigating potential risks.

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Build Your Bill of Materials
  • Define your product families and collaborate on continuous product management.
  • Full traceability with engineering change management to track your designs as they evolve.
  • Control the entire product design no matter what components you use — from electrical to mechanical to software to sensors to packaging to labeling.

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Bring Safer, Better Medical Devices to Market Faster

Benefits of Greenlight Guru for Startups

Effortless Implementation

Save time and money with our intuitive solution—it’s as easy to implement as it is to use. You’ll also be able to connect with our expert customer success team every step of the way.
Immediate Value

Once you have implemented our dedicated QMS for medical device success, you'll see an immediate uptick in productivity.
Scalable Partnership

We grow our services as your needs grow with your business. Need a few key areas of support? No problem. Need more support as you transition through the commercialization process? We’re here for you.
Standardized Processes

Greenlight Guru workflows are aligned to FDA and ISO standards for medical device predefined processes. Yes, you can take a breath now.

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.

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore resources that help MedTech startups get to market faster and more efficiently.

Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical. You’re just getting started, so you’ll want to connect with the best in the industry.

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Greenlight Guru Academy

Accelerate your learning and proficiency — both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

 Elevate Your Education
Resources

We have resources for all startup needs, whether you have a unique problem that needs solving or want to elevate your expertise.

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Community

Building a startup is hard. Make it easier by working with others who have been there before. Become a part of our community at any stage of the product development lifecycle and accelerate your path to market.

 Connect with Your Peers

Are You Ready to Experience the Greenlight Guru Difference?

With solutions to improve every stage of your product lifecycle and a team dedicated to supporting you, achieving excellence has never been easier.

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