Managing for Quality
November 1, 2001
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
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Under QSIT, QS requirements
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