<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Filter All Blog Posts

Product Development

Design Assurance: The Unsung Heroes of R&D

October 13, 2022
What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition,... Read More
Product Development

Guidance on How to Conduct Clinical Investigations Under EU MDR

October 13, 2022
The Questions and Answers guidance document from the European Commission's Medical Device Coordination Group (MDCG) provides answers to some of the outstanding questions for... Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

October 10, 2022
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

October 10, 2022
Read More
Product Development

MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU

October 9, 2022
MDCG 2020-5 is a guidance document put out by the European Commission (EC) to clarify the process for demonstrating equivalence with another CE marked medical device.  Read More
Product Development

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

October 7, 2022
The medical device industry has a lot of acronyms.  Read More
Product Development

Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?

October 7, 2022
On September 12th, 2022, FDA issued its latest draft guidance, which offers new recommendations for computer software assurance.  Read More
Product Development

Lessons from an Industry Leader: Playing the Long Game of MedTech

October 6, 2022
What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway?... Read More
Product Development

Generate MDR Compliant Clinical Data with Investigator-Initiated Studies

October 6, 2022
The number of Investigator-Initiated Studies (IIS’s) conducted globally is on the rise. Independent patient-focused clinical studies led by physicians play an integral role... 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