Conducting clinical studies in Italy.
Medical device manufacturers conduct clinical studies in Italy for various reasons, including the size of the Italian market and the presence of leading health-technology centres. This article discusses the manner in which the European requirements for medical device clinical investigations are interpreted and enforced in Italy.
Donawa
Maria
M
Donawa Consulting, Rome Italy. medonawa@donawa.com
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000592:standards; D017408:Guidelines as Topic; D007221:Industry / Q000331:legislation & jurisprudence / Q000592:standards; D007558:Italy