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Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices - Featured Image

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...
5 Steps to Faster-to-Market, More Profitable Medical Devices - Featured Image

5 Steps to Faster-to-Market, More Profitable Medical Devices

Healthcare provider market demands are such that medical device companies often find themselves in s...
Knowing vs. Doing as Medical Device Professionals - Featured Image

Knowing vs. Doing as Medical Device Professionals

For medical device professionals, there are the “knowers” and the “doers.”
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
Greenlight Guru Named Premier QMS Software for NIH RADx Initiative - Featured Image

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.
Pivoting Operations to Meet PPE Demand during Pandemic - Featured Image

Pivoting Operations to Meet PPE Demand during Pandemic

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...
Pros & Cons of Being a Physician turned MedTech Inventor - Featured Image

Pros & Cons of Being a Physician turned MedTech Inventor

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...
What is a Quality Agreement for Medical Devices? - Featured Image

What is a Quality Agreement for Medical Devices?

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Quality Management for IVD Devices vs Medical Devices - Featured Image

Quality Management for IVD Devices vs Medical Devices

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...
Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

Medical device labeling requirements are a key part of getting your device to market.
Understanding the Investigational Device Exemption (IDE) Process - Featured Image

Understanding the Investigational Device Exemption (IDE) Process

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...

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