Medical Technology Quality Assurance Needs Stronger Management Emphasis and Higher Priority

Examination of FDA's regulation of good manufacturing practices (GMPs) for medical devices, the scope of the current and the proposed GMP requirements, implementation of the current regulation, and industry compliance. Compares GMP requirements to generally accepted quality assurance standards; analyzes FDA program data; and examines GMP inspection results, compliance enforcement actions, and industry compliance in recent years. Graphs and charts.Medical Technology Quality Assurance Needs Stronger Management Emphasis and Higher Priority, with ISBN 9781568063300 and ISBN 156806330X.