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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

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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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Establishing a QMS

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Product Development
Etienne Nichols
May 11, 2023

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

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Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols
March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Product Development

Electronic Data Capture Systems vs. Paper-based Data Collection

Jon Bergsteinsson
March 24, 2023
In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More
Product Development

Making the BOM & Design Controls Connection

Niki Price
March 19, 2023
Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More
Establishing a QMS

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

Etienne Nichols
March 17, 2023
One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More
Product Development

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

Páll Jóhannesson
March 16, 2023
For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing research data to produce high-quality... Read More
Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols
March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More
Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols
March 10, 2023
The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More
Product Development

Complying with Good Clinical Practice in Clinical Data Collection

Jon Bergsteinsson
March 8, 2023
For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while... Read More
Product Development

How to Define User Needs During Design Controls

Etienne Nichols
March 3, 2023
Every medical device begins with the same purpose—to improve the quality of life by meeting the needs of its users. Read More

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

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.

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Community

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

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Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

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Resources

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

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