Clinical studies in Italy.
The requirements for conducting medical device clinical studies in Europe are not identical in all Member States. That is, variations exist in the way that the requirements in the European Directives are interpreted and enforced. This article provides an overview of the requirements that currently apply in Italy.
Donawa
Maria
M
Donawa Lifescience Consulting, Rome, Italy. medonawa@donawa.com
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000592:standards*; D007558:Italy; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence* / Q000592:standards*