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

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...

Tips for Virtual Audits Your Medical Device Company Can Implement Today

By Sara Adams on December 7, 2021

Auditing medical device manufacturers is one of the most important aspects of ensuring quality stand...

ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices

By Laura Court on December 3, 2021

For many medical devices, sterilization is the final step in the manufacturing process before they’r...

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

By Nick Tippmann on December 1, 2021

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — ...

Preparing for EUDAMED - Europe’s Medical Device Database

By Taylor Brown on November 30, 2021

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices ...

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