title: Regulation of medical devices outside the European Union.
authors.affiliation: Guildford Medical Device Evaluation Centre (GMEC), The Royal Surrey County Hospital, Guildford, Surrey GU2 7XX, UK. susan.lamph@nhs.net
authors.forename: Susan
authors.initials: S
authors.lastname: Lamph
mesh_terms: D003406:Credentialing / Q000331:legislation & jurisprudence / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004869:Equipment Safety / Q000145:classification / Q000592:standards; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D007883:Legislation, Medical / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing / Q000592:standards; D012015:Reference Standards; D012308:Risk Management