title: Designing medical devices for conformance with harmonized standards. The European Community's Medical Devices Directives and their effect on the product development process.
abstract: The European Community's Medical Devices Directives represent an ambitious effort to streamline the regulation of medical devices within the European Economic Area, and area comprising more than 380 million people. In this, the first of two special reports, Richard C. Fries and Mark D. Graber describe the Medical Devices Directives and their effect on the product development process. In the second report, appearing on page 294 Jean A. Goggins uses a case study format to demonstrate the process that would be used to gain European approval for a hypothetical medical device.
authors.affiliation: Support Engineering of Ohmeda Medical Systems Division in Madison, WI, USA.
authors.forename: R C
authors.initials: RC
authors.lastname: Fries
authors.forename: M D
authors.initials: MD
authors.lastname: Graber
mesh_terms: D001698:Biomedical Engineering / Q000295:instrumentation* / Q000331:legislation & jurisprudence / Q000592:standards*; D004282:Documentation; D004867:Equipment Design / Q000009:adverse effects / Q000379:methods / Q000592:standards; D004868:Equipment Failure; D004869:Equipment Safety / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D005062:European Union; D006801:Humans; D007391:International Cooperation; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards