Filter All Blog Posts

Product Development

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

April 9, 2023
Risk management is a notoriously complex subject—one that many people (including yours truly) have strong feelings about. Read More
Product Development

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

April 5, 2023
Patient-reported outcomes (PRO) are becoming increasingly important to medical device clinical trials. Your regulatory strategy, reimbursement strategy, marketing, and more... Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

April 2, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More
Product Development

Medical Device Adverse Event Reporting Regulations: EU vs. US

March 31, 2023
Regulatory authorities in both Europe and the United States require medical device companies to report on some adverse events (AEs) that occur during clinical investigations. Read More
Product Development

5 Tips for Running Effective Internal Quality Audits

March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. Read More
Product Development

How to Handle Medical Device Adverse Events

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

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

Explaining IVDR Classification for In Vitro Medical Devices

March 23, 2023
What is IVDR? The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation applicable to in vitro diagnostic medical devices. It establishes a risk-based... Read More
Product Development

Complete Guide to Bringing a Medical Device to Market

March 20, 2023
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.


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

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

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