mdr #software as medical device rule 11 (eu) 2017/745 #delphi medical devices mdcg #samd #mdr #performance #risk #softwaredesign #significantchanges #mdd #oracleforms windowsembedded security healthcare mdcg 2019-11 software qualification classification for software medical device software antonio bartolozzi #mdrart120 #mdcg #turboforms #porting #savemoney #olacleform #webapp #html5 clinical engineering windows7 windowsxp information security information technology windows cybersecurity risk bidimensional firewall whitelist soup ots softwaremedicaldevice tir57 tecnology tecnologia softwareengineering softwaredesign safety programming medicaldevice aami correct use abnormal use clinical investigation embedded software standalone sofware clincal benefit regulations classifcation guidance ivdr 2019-11 imdrf samd mdsw #medical module #telemedicine #mpi #ehr #en82304 #ce mark #rule 10 #rule 11 #2017-745 software design medical device sofwtare classification en 62304 class c class iii eu 2017/745 iec 62304 iec 13485 iec 14971 essential principles of safety and performance medical device design medical device interoperability compatibility 2017/745
Ver mais