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

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

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? - Featured Image

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

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...
Setting the Record Straight on Usability & Human Factors - Featured Image

Setting the Record Straight on Usability & Human Factors

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 - Featured Image

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

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? - Featured Image

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

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 - Featured Image

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

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 - Featured Image

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

Clinical testing of medical devices is a critically important step in ensuring the safety and effica...
Assessing the Global Regulatory Landscape - Featured Image

Assessing the Global Regulatory Landscape

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 - Featured Image

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

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 - Featured Image

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

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

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

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

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