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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

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...
25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition - Featured Image

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

By Leo Eisner on October 31, 2021
In this article you will find a comprehensive list of the most frequently asked questions from parti...
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...
Goodbye EN 1041. Hello ISO 20417:2021. - Featured Image

Goodbye EN 1041. Hello ISO 20417:2021.

By Ryan Behringer on September 6, 2021
When you’re trying to bring a new medical device to market, it’s normal to be focused on actually bu...
Understanding FDA's New Intended Use Rule and its Implications - Featured Image

Understanding FDA's New Intended Use Rule and its Implications

By Nick Tippmann on August 11, 2021
FDA published a final rule, which goes into effect the first of September, to amend its “intended us...
Does My Device Labeling Comply with 21 CFR 801? - Featured Image

Does My Device Labeling Comply with 21 CFR 801?

By Laura Court on June 28, 2021
Medical device labeling is a core requirement for getting your device onto the market.
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

By Nick Tippmann on April 7, 2021
Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

By Jesseca Lyons on April 4, 2021
Medical device labeling requirements are a key part of getting your device to market.
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

By Nick Tippmann on November 4, 2020
Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020
A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

By Jon Speer on March 22, 2020
With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020
Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

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