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How Should Artificial Intelligence in Medical Devices be Regulated? - Featured Image

How Should Artificial Intelligence in Medical Devices be Regulated?

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

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?

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

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

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Examining the HHS Proposal for Premarket Notification Exemptions - Featured Image

Examining the HHS Proposal for Premarket Notification Exemptions

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...
FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon? - Featured Image

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Would things be simpler in the medical device regulatory space if there was global harmonization acr...
Regulatory Tips & Pointers from a Former FDA Reviewer - Featured Image

Regulatory Tips & Pointers from a Former FDA Reviewer

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamle...
Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?) - Featured Image

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...

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