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CEN, the European standards body, recently released an amendment to the European edition of the medical device risk management standard, EN ISO.

Estonian standardization organizationJournal of the european unionEdwin billsOfficial journalEuropean unionMedical device directiveActive implantable medical device directiveVitro device directiveNotified bodiesContent deviationGeneral safetyPerformance requirementsRisk management policyNormative requirementsAnnexi chapterRisk management file