Risk management of European device clinical studies.
There is an increasing need to perform clinical studies to support device safety and performance claims. This article discusses risks associated with conducting European clinical studies of medical devices that are unrelated to risks concerning the use of the device. These can jeopardise the success of a clinical study regardless of the safety and performance aspects of the device.
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; D012308:Risk Management / Q000331:legislation & jurisprudence* / Q000592:standards*