Medical Device Quality, Regulatory and Product Development Blog

7 Project Management Tips

By Jon Speer on October 28, 2021

When I began my medical device career, I started as a product development engineer. Part of the role...

Project Management for Product Development of Medical Devices

By Nick Tippmann on October 27, 2021

How should you approach project management for medical device product development ? Stop managing yo...

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...

Medical Device 3D Printing: Should You Make the Move?

By Tom Rish on October 22, 2021

The medical device industry has grown immensely over the past several decades. But with new technolo...

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...

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

By Nick Tippmann on October 13, 2021

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, ...

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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