Design control--the ultimate protection?

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.

Mobile X-ray generators: a review.

Mobile X-ray generators vary widely in design, cost and radiographic performance and the new designs of recent years have led to the introduction of jargon. Such terms as 'capacitator discharge' and 'modicum frequency' can give rise to confusion regarding operating technique. This review classifies the mobiles into three distinct categories. Simple rules are presented to enable an operator to transfer exposure factors from one category to another, and an analysis of the relative merits of each category is provided. Part 1 provides a description of the categories available, a broad explanation of the principles involved and discusses the radiographic use. Throughout the text certain terms are given in italics when first used in that particular description and Part 2 gives full explanations of these terms in the context of Part 1.