Medical Device Quality System Regulations – A Brief Overview of FDA Requirements

• By: Staff Editor
• Date: September 15, 2011

As medical devices become increasingly available for home use and more use-accessible and friendly, it has become important for manufacturers to ensure the product’s quality, safety and reliability. Medical device quality regulatory requirements issued and enforced by agencies such as the FDA act as a valuable guide for manufacturers.

This article gives a brief overview of the FDA’s medical device quality system regulations.