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

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

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

A Regulatory Gap Analysis of FDA's Systems & Policies

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improv...
3 Medical Device Security Challenges (and Solutions) - Featured Image

3 Medical Device Security Challenges (and Solutions)

Technological innovations in and around the medical device industry have made it possible for compan...
How Do FDA Medical Device Recalls Work? - Featured Image

How Do FDA Medical Device Recalls Work?

For medical device companies, few things are as valuable as the public’s trust.
Tips For Being Prepared Post-EUA (Emergency Use Authorization) - Featured Image

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

Does your company have products that were granted emergency use authorization to get to market? Assu...
ISO 11137: An Introduction to Gamma Sterilization Validation - Featured Image

ISO 11137: An Introduction to Gamma Sterilization Validation

For many medical device companies, sterilization is one of the final hurdles they have to clear befo...
Understanding the UDI System for Medical Devices - Featured Image

Understanding the UDI System for Medical Devices

Do you understand how the Unique Device Identification (UDI) system in the medical device industry w...
Most Popular Medical Device Content in 2021 - Featured Image

Most Popular Medical Device Content in 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 - Featured Image

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

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 - Featured Image

How Augmented Reality (AR) is Revolutionizing Healthcare

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

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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