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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

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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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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Ideation & Prototyping

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Jeff Perkins
September 18, 2023

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

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featured

Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
May 11, 2023
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Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Chris Rush
August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
Post-Market Surveillance

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

Páll Jóhannesson
August 4, 2023
The latest SMART-TRIAL by Greenlight Guru update includes a newly designed Reporting module that streamlines clinical data management for scaling medical device companies. By... Read More
Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

Jesseca Lyons
June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Product Development

Managing Major Changes to Medical Device Packaging

Etienne Nichols
May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More
Product Development

5 Tips for Designing a Medical Device Study Under FDA Requirements

Páll Jóhannesson
May 26, 2023
Let’s face it—medical device clinical studies are no walk in the park. There are so many variables to consider, such as patient recruitment, study design, and regulatory... Read More
Product Development

What is a Modern QMS?

Etienne Nichols
May 26, 2023
For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function. Read More
Product Development

4 Tips for Managing Your MedTech Portfolio

Etienne Nichols
May 24, 2023
There’s no doubt that MedTech is a noble industry, built on the mission of improving the quality of life with impactful medical devices. Read More
Product Development

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

Jon Bergsteinsson
May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

Etienne Nichols
May 16, 2023
Medical devices are intended to save and improve quality of life. 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.

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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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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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