title: Understanding the medical device directive changes.
authors: National Standards Authority of Ireland, Nashua, NH, USA.
authors: Claire
authors: C
authors: McKenna
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019544:Equipment Failure Analysis / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D011785:Quality Assurance, Health Care / Q000592:standards*