New efforts to harmonise clinical evaluation.
Manufacturers wishing to market globally face varying regulatory requirements for assessing and analysing clinical data in support of medical device safety and performance claims. This article discusses the need for harmonising these requirements and two proposed documents developed to address this need.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004389:Durable Medical Equipment; D004869:Equipment Safety; D005060:Europe; D005069:Evaluation Studies as Topic; D014481:United States; D014486:United States Food and Drug Administration