The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enf...

The debate over how to tame private medical spending tends to pit advocates of government-provided insurance--a single-payer scheme--against those who would prefer to harness market forces to hold down costs. When it is mentioned at all, the possibility of regulating the medical industry as a public utility is brusquely dismissed as anathema to the American regulatory tradition. This dismissive...