Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

By Etienne Nichols on March 2, 2022

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...

What are the Opportunities for Improvement (OFI) for Quality?

By Nick Tippmann on February 23, 2022

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportuniti...

Design vs. Utility Patents: Choosing the Right One for Your Device

By Wade Schroeder on February 4, 2022

If you go through the rigors of designing and developing a medical device, it only makes sense that ...

A Regulatory Gap Analysis of FDA's Systems & Policies

By Nick Tippmann on January 26, 2022

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improv...

3 Medical Device Security Challenges (and Solutions)

By Tom Rish on January 16, 2022

Technological innovations in and around the medical device industry have made it possible for compan...

How Do FDA Medical Device Recalls Work?

By Taylor Brown on January 14, 2022

For medical device companies, few things are as valuable as the public’s trust.

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

By Nick Tippmann on January 12, 2022

Does your company have products that were granted emergency use authorization to get to market? Assu...

ISO 11137: An Introduction to Gamma Sterilization Validation

By Etienne Nichols on January 7, 2022

For many medical device companies, sterilization is one of the final hurdles they have to clear befo...

Understanding the UDI System for Medical Devices

By Nick Tippmann on January 5, 2022

Do you understand how the Unique Device Identification (UDI) system in the medical device industry w...

Most Popular Medical Device Content in 2021

By Nick Tippmann on December 19, 2021

At Greenlight Guru, we’ll never forget 2021. It was a big year of growth for us, our customers, and ...

UDI: Everything You Need to Know About Unique Device Identifiers for the FDA

By Wade Schroeder on December 10, 2021

Every aspect of the medical device industry needs to be built on the highest standards for quality a...

How Augmented Reality (AR) is Revolutionizing Healthcare

By Nick Tippmann on December 8, 2021

Technology can accelerate the transformation of healthcare to improve health, quality of life, safet...

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