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

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

By Tom Rish on November 8, 2021

To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical d...

Failure Mode Effects Analysis: What Is It & When Should You Use It?

By Ryan Behringer on November 4, 2021

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...

Setting the Record Straight on Usability & Human Factors

By Nick Tippmann on November 3, 2021

What is usability? Human factors? Are they one and the same or different in the medical device indus...

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...

What’s the Difference Between Clinical Evaluation and Clinical Investigation?

By Laura Court on October 26, 2021

Within the myriad of regulations and standards governing medical devices, there are a number of simi...

IEC 62366 Explained: What You Need To Know About Usability Engineering

By Etienne Nichols on October 24, 2021

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on desi...

Clinical Testing for Medical Devices: What US Manufacturers Need to Know

By Wade Schroeder on October 21, 2021

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...

Assessing the Global Regulatory Landscape

By Nick Tippmann on October 20, 2021

With medical device regulations tightening around the world, especially in Europe, it's important to...

Ultimate Guide to QA & RA in Medical Device 3D Printing

By Formlabs on October 17, 2021

This document aims to guide users in the medical device industry through every stage of the product ...

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

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

By EMERGO by UL on October 12, 2021

ANSWERED ON THIS PAGE: What are the responsibilities of an EU Authorized Representative (EC REP)? Ca...

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