Managing for Quality

Originally Published MX November/December 2001

GOVERNMENTAL & LEGAL AFFAIRS

Managing for Quality

Enterprisewide management systems can help device manufacturers comply with FDA CAPA requirements.

Marie Fair

In today’s fast-paced economy, managing product quality and customer satisfaction is a tremendous challenge for any medical device company. The ability to manage, correct, and prevent product-quality issues can be a crucial component of a device company’s success or failure. Device manufacturers are held to especially high quality standards by FDA and other government agencies to ensure that their products are safe and effective.

The Federal Food, Drug, and Cosmetic Act requires FDA to conduct biennial quality system (QS) and good manufacturing practices (GMP) inspections of companies that manufacture Class II or Class III medical devices.¹ In an attempt to decrease inspection time and sharpen the focus of medical device inspections, FDA developed an approach for conducting inspections under the QS regulation called the quality system inspection technique (QSIT).²

Under QSIT, QS requirements