Biomedical instrumentation & technology / Association for the Advancement of Medical Instrumentation
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Biomed Instrum Technol · Jul 1995
Designing medical devices for conformance with harmonized standards: a case study of non-active implants.
The European Community's Medical Devices Directives represent an ambitious effort to streamline the regulation of medical devices within the European Economic Area, an area comprising more than 380 million people. In this, the second of two special reports, Jean A. ⋯ Fries and Mark D. Graber describe the Medical Devices Directives and their effect on the product-development process.