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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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A Software Validation Model Like No Other

As a MedTech company, you must validate the software used to bring your products to market. It’s important to do, but it’s also extra work and not your primary focus. That’s why we do the bulk of the work and give you a complete and comprehensive software validation package. With completed IQ and OQ documents, PQ templates, and ongoing support, Greenlight Guru does the heavy lifting so you can focus on developing your devices.

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

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Validating Your QMS Shouldn’t Be A Burden

Managing IQ, OQ, and PQ documents on your own is a time-consuming and expensive process. It distracts you from using the software you bought to help you deliver your product and ultimately affects time to market. Don’t stall. Hit the ground running with Greenlight Guru.
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Not Optional: A Validation Solution Designed For You

With a dedication to the medical device industry, we not only deliver a purpose-built system but also the most complete validation solution at no additional cost to ensure your success. Why? We know you need it, and we won’t put validation costs in the way of your success.

Unparalleled Expertise

You receive ongoing support from the Greenlight Guru team to meet your needs and answer any questions you may have, from implementation to major updates to our system and anytime in between.

Risk-Based Approach

Our validation process emphasizes data integrity, reduced risk, and product quality using a risk-based approach that considers factors of complexity, criticality, and hazards as directed by current FDA guidance.

Uninterrupted Compliance

With Greenlight Guru, you receive a complete validation package with every major update so you can continue developing your devices while staying compliant. Revalidate with ease, including review of completed IQ/OQ and fast updates to your PQ.

Learn Why Every Customer Relies On Our Validation Package

With Greenlight Guru, you can spend your time building life-changing medical devices, rather than constructing complex validation protocols for software intended to help you. Our validation package does everything for you that software vendors should do.

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trusted by 1000 +

medical device companies

1700 +

510(k) clearances and CE markings

2000 +

ISO 13485 certifications

$ 125 k

saved on average per project
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A Shared Responsibility Model

We Manage: networking, storage, server HW, virtualization, servers, databases, security & integration, runtimes, and validation.


You Manage: developing your devices and periodic reviews of your software validation.