Medical Device AIMDD Active Implant Instruction Se
AIMDDinstructionwasdrawnupin1990andwasappliedforcompulsorymatterssinceJanuary,1995.Therefore,sellingactiveimplantmedicaldeviceinEuropemustpasteCEtags.ManufacturersmustprovetothecertificationauthoritiesthatproductswhichpasteCEtagsmeettheAIMDDinstructi***:TypetestingDesigningevaluationMedicaldeviceevaluationforproducers(ISO13485/ISO9001)ClinicalreportevaluationMeettherequirementsonallthemedicaldevicesinstructi***.O***unda,ac***ultingorganizationengagedinmedicaldevicesregulati***c***ulting,medicaldevicesregistrationagent,medicaldevicemanagerialsystemcertificationandmedicaldeviceproductscertification,focusesonprovidinginternationalmedicaldeviceregistration,medicaldevicesystemcertificationformedicaldeviceenterprises.Besides,o***undacanhelpmedicaldevicesupplierswithauditionofthesecondandthirdpartyandexaminegoodsforexport,providinginformationofmanufacturinglicensec***ultingservice.)