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

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.

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.

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.

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.

loopMark

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

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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

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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

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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

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

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

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.

Become a Partner

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.

Explore Our Content Hub

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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Explore Resources for Startups

15 Items Medical Device Startups Need to Address

Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.

Get the Checklist

Global Medical Device Podcast

Building a Startup in the MedTech Industry

Episode 186

Checklists and Templates

Content Toolkit for Medical Device Startups