Clinical Login Support Contact Sales
Products

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Accelerate development with integrated design control and risk software.

Learn More

Featured Capabilities:

Design Controls Risk Management Risk Intelligence

Schedule a custom demo of Greenlight Guru Product now.

REQUEST A DEMO

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

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

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
Pricing
Request a Demo
Request a Demo

Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

View Post
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
View Post
featured

Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
View Post

Filter All Blog Posts

Showing Results for

Clinical Data Collection

Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations

Chris Rush
April 3, 2024
If there is one universal truth in MedTech clinical trials, it is that your study will take more time than you allot for it initially. Everyone, and I mean everyone,... Read More
Regulatory Submission

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

Etienne Nichols
April 2, 2024
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market. Read More
MedTech Lifecycle Excellence

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

Sara Adams
March 27, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, respondents cited a number of common challenges related to training management, including: Read More
MedTech Lifecycle Excellence

FDA's Voluntary Improvement Program

Etienne Nichols
March 21, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss... Read More
MedTech Lifecycle Excellence

The State of UDI Across the World

Etienne Nichols
March 7, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and... Read More
MedTech Lifecycle Excellence

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

Etienne Nichols
March 5, 2024
In MedTech, an increasing number of companies are introducing devices integrated with AI technologies. Read More
Clinical Data Collection

Outsourcing Clinical Activities in 2024: Choosing A CRO

Chris Rush
March 4, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, 70% of respondents told us they were going to outsource at least some of their clinical activities to a... Read More
Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

Wade Schroeder
February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
MedTech Lifecycle Excellence

Quality Myths & Lessons Learned Part II

Etienne Nichols
February 22, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. 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.

 Elevate Your Education
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.

 Find Your Community
Partner Ecosystem

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

 Become a Partner
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.

 Explore Our Content Hub