November

November 29, 2013

Regulations for Medical Devices in America

In America, the FDA’s Center for Devices and Radiological Health, or CDRH, is responsible for regulating the firms that manufacture, repackage, relabel, or import medical devices […]
November 27, 2013

How to get new medical device approved?

If you are trying to market a medical device, the Food and Drug Administration, or FDA, must clear your product for medical compliance. There is a […]
November 25, 2013

How to Get a New Drug Approved

Companies that make drugs are always analyzing various compounds trying to find the ones that have the most therapeutic value. There are many steps, millions of […]
November 22, 2013

What is an eCTD?

An Electronic Common Technical Document, or eCTD, is a standard for electronic submission containing regulating information to regulated agencies. The document is an easy and quick […]
November 20, 2013

What Are the FDA Guidelines for Food?

If you have ever wondered how the Food and Drug Administration handles food guidelines, there is plenty of information you can learn about here and at […]
November 18, 2013

How Does the FDA Regulate Medical Devices?

There are many basic regulatory requirements that manufacturers and importers consider when they market medical devices. These rules are to aid foreign governments to understand the […]
November 16, 2013

Who Regulates Medical Devices?

The FDA, or Food and Drug Administration, is an agency inside the U.S. Department of Health and Human Services. It makes up the office of the […]
November 14, 2013

Regulations for Medical Devices

Medical devices can be anything from highly refined computerized medical equipment down to a wooden tongue depressor. There are multiple international classification components to categorize medical […]
November 12, 2013

What is Medical Compliance?

Medical compliance is the different laws and regulations that the FDA creates in the United States for the health and well-being of the consumer. There are […]
November 6, 2013

How Long Does a Knee Replacement Last?

When knee replacements began to be used in the early ‘70s it was the common thinking that they would last maybe 10 years before needing to […]
November 4, 2013

Recent Advances in Joint Replacements

In the United States alone there are around 200,000 total hip replacements and almost 500,000 total knee replacements each year. Most experts estimate that by the […]
November 2, 2013

What is the Gynecomastia Procedure?

For men who have gynecomastia, or enlarged breasts, there can be a lot of negative emotions. They may feel shame, insecurity or humiliation because of the […]