TUV南德-欧盟医疗器械新法规MDR专题培训

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Addvalue.Inspiretrust.GreaterChinaETUVSUDffi/I,|EMDR*+F,t&Hl;it;.i:;tit'k*tu{t0:ii'adtuirryrPtud'ddto&dd:ld11'trlddh*s,&to!M':ml$ICRSffillcl$lln:nii+lbilci\lXlm{iqdqcidMd{I5[lDd[trICI'ftlstuittllilsdtotuWPtudddil!Ctrdd:ldXl:ilhffiiirysddMdqdtDm.SlI(uhn!,flks0ll0::'itIlwtnkalDocumentationinformmanufacturer/.epresentativeHrcingonmko{IgsnnwdbrfuBilffimddngmlhbleputinginbsorvicen*lngr&!hpu0ngidosorylet**-:_l1glEss-ejtialRequhementslll,llb,llbimp'lla,Pndil1Conlofft)tty()ilahty^rLt!];tQallnni-lyJlerlChaplerilAsscss/iletlolTr:tini::.tlDci:lntk)il,.;,tti{inDoCAnnexlXCltp.l+ll'lilAnnexlXchapterl+lll,andMDRfrAt$i+EiafE'.,\\PrcductConlormttyVerificalionQualitYManagenentSystemChapterllA5s6svnenlolfectuicalDocunentationDoCAnnexlXChapteri+ll+lilmTovsoDit/rnMDRrF{f,n&f;gGt**ilttff**(csPR)Eftf*rr*xAffitiw|ftrtrif'FffirgB6&cEtfiitArticle10(9)AnnexlXChapterIAnnexlXChapterIyB++IrXilruvsuoirfimyppg{grtntsEttzr*frffilsFurf;EGSPRffiH-GeneralSafety&PerformanceRequirements_'l{.\^AYrU&Arstu14&,srrr5A5\AE:o€Fte,!crf,E!L.MHSGOT9fo65lltt/*,,it)K*tr'*iltrefitwf*&KErrfftf;i*x[****filsfa**(csPR)nffitrrftatrtrfiFffir;ettnr0vsuDit/fEuoRlFtd.$*ilnmrlxft{s*tr*trf*eEErmsf;=,ftIttt**fttrrc*(cspR)fftrtrfF*rr.bit'FffifiPostMarketSurveillanceSafety&Clinicalperformance(SSCP)Article32Classlll&implantable4e,{(,:,riWnna*fi?*6fi*ftH&Xffi*t**fiitte**(csPR)fHHacrtilSKa122lfltt*Arlicle22system&procedurepacksCAMD(CompetentAuthorityforMedicalDevices)httos://)r'ru^,n''r'a_.rLF[{Or;lvDFIr',i.r{(:lr\rAbouttheMDR/IVDRTronsitionSubgroupli.r4yobt6nvc!4lthoTrdn.trnr!!bq'Dlpnr.ro,dcirl/orr-or$t,lrtfi.r!o(rtLolio.irL:o.r,!rcirtoppl..rt,on'ro!bkrrrcoirj!;n:,onnprcv04'c...rncnd.tdrsorddrity\rhotlrrn.loqlojoi:an.r.rfj*r!!do.il.1o.rorn!optrotor,.srrcrcocF.opf,orcrccf.csarnpllr.Jrdsprfp4cosolsResourcesTh.uORlVlclidn.trof:rbgrnu![csCovr-jopcd]e14fiQs!op.orrd.rr..try'tAqs^Moea.onstrro.olpro!iiront.raqsrvDeTronsrtionolpr!vixion!--¡ªGuidance!ffi,'::,::ffi:::isff:iff:-'i::'i,a?:'.'n€'tuh6bb''dd'kh''d'E''{o@tuv-sud.cnAddvalue.Inspiretrust.TUVSUDisatrustedpartnerofchoiceforsafety,securityandsustainabilitysolutions.ltspecialisesintesting,certification,auditingandadvisoryservices.Throughmorethan24,000employeesacrossover1,000locations,itaddsvaluetoitscustomers,inspiringtrustinaphysicalanddigitalworld.Contactustolearnmore.Shanghai

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