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Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues - Featured Image

Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues

By EMERGO by UL on October 15, 2021
So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, mark...
Software as a Medical Device: Definitions, Examples & Regulatory Framework - Featured Image

Software as a Medical Device: Definitions, Examples & Regulatory Framework

By Wade Schroeder on October 14, 2021
Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...
European Authorized Representative for Medical Device Companies - Featured Image

European Authorized Representative for Medical Device Companies

By EMERGO by UL on October 12, 2021
ANSWERED ON THIS PAGE: What are the responsibilities of an EU Authorized Representative (EC REP)? Ca...
3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

By Etienne Nichols on October 10, 2021
If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)? - Featured Image

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

By Sara Adams on October 7, 2021
Quality management is an essential part of manufacturing any product, regardless of size, complexity...
When to Throw the Least Burdensome Flag on FDA - Featured Image

When to Throw the Least Burdensome Flag on FDA

By Nick Tippmann on October 6, 2021
What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional infor...
What is an ISO Audit? - Featured Image

What is an ISO Audit?

By Sara Adams on October 5, 2021
When it comes to medical devices, compliance isn’t based on the honor system.
How Should Artificial Intelligence in Medical Devices be Regulated? - Featured Image

How Should Artificial Intelligence in Medical Devices be Regulated?

By Ryan Behringer on September 21, 2021
Take a close look at any global industry and you’ll find them all locked in the same race toward inn...
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc - Featured Image

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

By Nick Tippmann on September 15, 2021
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...
What is the FDA Medical Device Registration Process? - Featured Image

What is the FDA Medical Device Registration Process?

By Laura Court on September 14, 2021
To patients and providers, medical devices are more than a product. They serve as the conduit to bet...
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

By Wade Schroeder on August 8, 2021
As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

By Nick Tippmann on June 23, 2021
A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...

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