Design control--the ultimate protection?

Abstract

Over the last decade or so, medical device manufacturers with customers in the United States and the United Kingdom should have discovered the benefits of using quality systems in their manufacturing process. Both the American GMP Regulations (21 CFR-820)--enforced by the U.S. Food and Drug Administration (FDA)--and the U.K. Department of Health Guides to Good Manufacturing Practice based upon BS 5750: Part I (1979)--enforced through the National Health Service supply chain-- have been applied with the objective of ensuring the availability of safe and effective medical devices. This article examines the design control aspects of a quality system and asks whether the medical device industry should be suspicious of third-party assessments of confidential documentation.