Design Control

The attached article by Master Control (a manufacturer of medical device quality control software) is a good reference for companies that design medical devices. In particular, if your quality system is weak, you may want to read this. Keep in mind that quality control procedures are not "computer dependent" in the sense that you need a computer software system to comply with the FDA's requirements. In fact, BesTech offers a comprehensive FDA-compliant quality control system that includes design control. This system is paper-based, keeping the cost low. Read Quality By Design and also check out BesTech's download page for additional information on Design Control.