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Product Development

7 Project Management Tips

October 28, 2021
When I began my medical device career, I started as a product development engineer. Part of the role included—right, wrong, or indifferent—project management. And I’ve found... Read More
Product Development

Project Management for Product Development of Medical Devices

October 27, 2021
How should you approach project management for medical device product development ? Stop managing your projects using methods and tools that delay timelines and... Read More
Product Development

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

October 26, 2021
Within the myriad of regulations and standards governing medical devices, there are a number of similar terms that tend to be used interchangeably within the industry, even... Read More
Product Development

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

October 24, 2021
Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on designing a user interface (UI) that allows people to quickly understand how... Read More
FDA Regulations

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

October 22, 2021
The medical device industry has grown immensely over the past several decades. But with new technological advances being made on a near-daily basis, the pace of growth is... Read More
Product Development

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

October 21, 2021
Clinical testing of medical devices is a critically important step in ensuring the safety and efficacy of medium to high risk products. It’s one of the presumed protections... Read More
Product Development

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

October 17, 2021
This document aims to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D... Read More
Product Development

Software as a Medical Device: Definitions, Examples & Regulatory Framework

October 14, 2021
Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of talented engineers and developers, it’s an infinite toolbox that can improve... Read More
Product Development

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

October 10, 2021
If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, and more—you may notice they have a symbol on them that looks like this: Read More

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