The End-to-End Platform Built for MedTech Lifecycle Excellence



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


Close the Gaps

Controlling critical data and documenting processes can quickly get lost in the weeds at high-growth MedTech companies. What no one tells you is how gaps in these activities impact your commercialization journey. Add in regulatory and compliance requirements to your development goals, and it only gets more challenging. Just a QMS isn’t enough anymore. Your teams need more.

Your MedTech Lifecycle Excellence Platform

Greenlight Guru is more than your generic QMS software provider. We give you what you need – consistency and flexibility with a seamless, compliant
source of truth.

Document Management
Change Management
Risk Management
Multi-level Design Controls
Product Management
Quality Process Management
Training Management
AI/ML Advantages
Document Management Change Management Risk Management Multi-Level Design Controls Product Management Quality Process Management Training Management ML Advantanges-01

Key Solution Features

While our end-to-end system covers a wide range of your business’ needs, we’ve identified five key areas that often overwhelm medical technology companies.

Quality Management

Consistently impress auditors and investors with an unbeatable QMS. Where there are data or process gaps, Greenlight Guru’s QMS fills them for you.

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Product Development

Successfully collaborate and execute on product development with our integrated design control and risk solution. From research and design to launch and postmarket surveillance, we're here to enable the success of your medical device development every step of the way.

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Get continuous clinical evaluation and trial data management to simplify compliance and reduce costs.

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End-to-end Support Throughout the MedTech Lifecycle

Discover how our industry-dedicated platform accelerates the delivery of life-changing medical devices to all of humanity throughout your product’s lifecycle.


Have the ability to identify unique problems and unmet needs of patients with software that enables collaboration and outcome-driven thinking.


Establish initial QMS procedures with software that makes managing training, documents, processes, instructions, and internal audits easier than you ever thought possible.


Streamline product development with design control and product development software that keeps innovation, quality, and traceability at the forefront.


Move forward to regulatory submission with confidence by leveraging a platform that goes beyond baseline compliance requirements.


Support validation, verification, and design transfer as you break into the market. Launch, manufacture, and distribute life-changing medical technology.


Control the efficacy of your product with postmarket surveillance software that unlocks full traceability of quality events, including nonconformances, customer feedback/complaints, and CAPAs.


Excellence requires iteration. Improve the quality of life through your product by consistently meeting user needs. Learn industry best practices and unlock continuous improvement.

Are You Ready to Experience the Greenlight Guru Difference?

1000 +

trusted by medical device companies

1700 +

510(k) clearances and CE markings

2000 +

ISO 13485 certifications

1000 +

other approvals and audits passed

More Than Software to Fill the Gaps

Even with great software, MedTech companies fail every day. Succeed with Guru Edge. Whether you’re looking for advice from like-minded professionals or researching the latest MedTech trends, we have you covered with comprehensive, industry-specific services, tools, and education.


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

Elevate Your Education

We’ve created a network of your peers for inspiration and shared experiences. Connect to others and accelerate your path to success, no matter where you are in the product lifecycle journey.

Find Your Community
Partner Ecosystem

We’ve built a partner network of hundreds of consulting firms in quality, regulatory, testing, design, and clinical so you can get the right help for your business needs.

Learn More About Partners

Our Content Hub contains a wealth of resources for your team–from all things Greenlight Guru to MedTech knowledge and process problem solving, we have curated resources that will help you improve the quality of life for your patients.

Explore Our Content Hub
Dedicated Customer Success

We go beyond software support. We’re here to help you achieve workflow efficiencies, increase team collaboration, maintain compliance, and get your product to market quickly and safely. Your outcomes shape our outcomes – when you succeed, so do we.

Connect With Our Team
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