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

The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers

By Etienne Nichols on November 12, 2021

The internet of things (IoT) is a blanket term used to describe the billions of connected objects an...

3 Non-negotiables for Managing Business Risk as a Medical Device Company

By Taylor Brown on November 11, 2021

How seriously do you take risk management? This may seem like an inane question, especially for a pr...

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...

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...

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 ...

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...

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

By Etienne Nichols on October 10, 2021

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

By Sara Adams on October 7, 2021

Quality management is an essential part of manufacturing any product, regardless of size, complexity...

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