title: Designing medical devices for conformance with harmonized standards: a case study of non-active implants.
abstract: 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. Goggins uses a case study format to demonstrate the process that would be used to gain European approval for a hypothetical medical device. In the first report, appearing on page 284, Richard C. Fries and Mark D. Graber describe the Medical Devices Directives and their effect on the product-development process.
authors.affiliation: Meadox Medicals, Inc. Oakland, NJ, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Gogins
mesh_terms: D001672:Biocompatible Materials / Q000592:standards; D001698:Biomedical Engineering / Q000295:instrumentation* / Q000331:legislation & jurisprudence / Q000592:standards*; D001807:Blood Vessel Prosthesis / Q000592:standards; D004867:Equipment Design / Q000379:methods / Q000592:standards; D004869:Equipment Safety / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D006801:Humans; D011356:Product Labeling; D019736:Prostheses and Implants / Q000592:standards*; D011474:Prosthesis Design / Q000592:standards; D011786:Quality Control; D018570:Risk Assessment; D013242:Sterilization
chemical_list: D001672:Biocompatible Materials