title: Medical devices on trial, Part I.
abstract: This is the first of a two-part article exploring the place that clinical research plays in today's medical device industry. Part I looks at the differences in development processes between drugs and devices and examines future trends for increased requirements for clinical data in the device sector.
authors.affiliation: Celsus, London, UK. dwright@celsusresearch.com
authors.forename: David
authors.initials: D
authors.lastname: Wright
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence; D001709:Biotechnology / Q000295:instrumentation* / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000379:methods*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D011786:Quality Control; D014481:United States