medical compliance

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 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 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 […]