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1ELECTRO-MEDICALDEVICESINTRUSTEDHANDSSGSISTHEWORLD'SLEADINGTESTINGANDCERTIFICATIONCOMPANYCONSUMERTESTINGSERVICESELECTRICAL&ELECTRONICSELECTROMEDICALDEVICES2SGSMEDICALNETWORK:THEAsamedicaldevicesmanufactureryourfocusistocreateproductsthatimprovethequalityofmedicalservicesprovidedaroundtheworld.
Butbetweenyourdevicesandthemedicalprofessionalsthatshouldusethemstandahostofmarket-specificregulatoryrequirements,alonglistofcompetitors,variousclient-definedqualitystandardsandaneedtospendtimeandresourcesbeyondwhatyoumightbewillingtoinvest.
SGSistherightglobalpartnertohelpyouovercomethesehurdlesfastandputyourproductsinthehandsofmedicalprofessionalsworldwidetoday.
KNOWALLAPPLICABLEREGULATORYREQUIREMENTSToensurethemarketsuccessofyourmedicaldevicesyouneedtoknowandcomplywithalltheregulationsapplicableonallthemarketsyouaretargeting.
Theseincludedirectivesandstatutoryrequirementsspecifictomedicaldevices,andtheoverlappingregulationsthatcoveryourproduct.
Thesooneryouintegratethesevariablesinyourproductdevelopmentprocessthelessresourcesandtimeitwilltaketoputyourproductsonthemarket.
Inanindustrywherestayingonestepaheadofcompetitorsisessentialthiswillhelpensureyourproductsgetinthehandsofmedicalprofessionalsbeforethoseofyourcompetition.
SGShastherightindustryknowledgeandmarketexperiencetohelpyoustayontopofallregulatoryrequirements.
ThankstoitsglobalnetworkofmedicaldevicesspecialistsSGScandispatchanexpertlocatednearyoutoassistinidentifyingtherelevantregulationsandintegratingcomplianceindicatorsinyourproductdevelopmentprocess.
ENSUREAFASTGLOBALREACHFORYOURMEDICALDEVICESAsyouintendtotargetcustomerslocatedinvariouspartsoftheworldyouneedalocalpartnerthatwillhelpensureyourproductsgainquickaccesstoavarietyofmarkets.
Ournetworkofmedicaldevicesexpertsspansonallcontinents,coveringallmajormarkets.
ThismeansthatthroughyourlocalSGStechnicalteamyoucanstreamlinethemarketaccessprocess,oneproductsubmissionwillenableyoutogaincompleteregulatorysolutions.
YoucanreceivecertificationsformultipleglobalmarketswhileworkingwithSGSexpertslocally,inyourownlanguage.
Thiswillfurtherreducetheamountofresourcesyouspendwithprojectmanagementprocesses.
Regardlessofwhereyouarelocatedandwhereyouwanttosendyourproducts,yourlocalSGSmedicaldevicesteamwillmanageallyour3rdpartytesting,technicalfileassessments,auditsandtrainingneeds,trulybringingaworldofexpertiseatyourdoor.
3PARTNERYOUNEEDPROVIDEQUALITYANDADDEDVALUETOYOURCUSTOMERSBesideprovingthatyourproductsarebetterthanthoseofyourcompetition,youalsoneedtobeabletoprovethatyoumeetindustryandclient-specificstandardsforqualityandsafety.
PartneringwithSGS,yourbusinesswillbebackedbyaglobalnetworkwithaproventrackrecordforraisingqualitylevelsthroughoutentireoperations,fromproductsandsupplychainstoemployeeandsustainabilityprogrammes.
Thankstoourglobalreputationandcomprehensiverangeofaccreditations,SGStestreportsincreasethevalueandqualityofyourproductsintheeyesofbothregulatorybodiesandglobalplayersinthemedicalindustry.
WhenyourproductsfulfilourownqualityandsafetyrequirementstheyaregrantedSGScertificationmarks,whicharerecognizedbycustomersaroundtheworldassignsoftrusted,qualityproducts.
4ACCESSTHECOMPLETESERVIAchievingafasttimetomarketrequirescomprehensiveregulatoryknowledgeandaflexibleapproachinestablishingthemostsuitedassessmentprocedure.
Withspecificcombinationsoftestsandauditsyoucanensurecompliancewithrequirementsofmultiplecertificationsatthesametime.
TESTINGOurtestingportfolioincludes:EU/INTERNATIONALPRODUCTSAFETY,includingtestingtotheIEC/EN60601andIEC/EN61010seriesandtheCBschemethatcoverstestingrequirementsofover52countriesUSNRTL(ULStandards)andSTANDARDSCOUNCILOFCANADAEMCTESTING(IEC/EN60601-1-2,andIEC/EN61326seriesincludingCBScheme)ApprovalforOVERLAPPINGECDIRECTIVES:MachineryDirective,PersonalProtectiveEquipment;PressureEquipment;NonAutomaticWeighingEquipment;R&TTEFUNCTIONALSAFETYWIRELESSTESTING/TELEMEDICINERECHARGEABLEBATTERIES,arerequiredtomeetIEC62133fortheCBscheme.
IntheUS,UL2054appliesRESTRICTEDSUBSTANCETESTING,includingtestingtoRoHS2requirementsforMedicalDevicesPACKAGINGTESTINGCERTIFICATIONOurrangeofregulatoryandqualityauditandcertificationservicescoverthefollowingrequirements:ISO13485ISO9001andISO1400193/42/EECasamendedby2007/47/EC(MedicalDevicesDirective,CEMarkingforEurope)98/79/EC(InVitroDiagnosticMedicalDeviceDirective,CEMarkingforEurope)CMDCAS(CanadianMedicalDevicesRegulations)510(k)SUPPORTSERVICESfortestdata,advisory,andfactoryfollow-upU.
S.
Food&DrugAdministration(FDA)SITEINSPECTIONSJPAL(JapaneseRegulationsforMedicalDevices)OTHERECDIRECTIVES(CEmarkingofPPE,PressureVessels,NAWI,andmore)GlobalRegulatoryCertifications,includingthirdpartycertificationsforTaiwan,Australia,HongKongandBrazil(INMETRO)ANDMUCHMOREOtherservicesrelatedtomedicaldevicesinclude:BIOCOMPATIBILITYEVALUATIONBiologicalevaluationofmedicaldevicesaccordingtoISO10993AUDITS-SupplierAudits,GapAnalysisAuditsandPharmaceuticalandCosmeticGMPAuditsCLINICALTRIALSHYGIENICQUALIFICATIONofproductionfacilitiesMICROBIOLOGICALTESTSOFPRODUCTSbeforeandaftersterilizationPRODUCTCONTROLFORPOSSIBLETOXICRESIDUESfromthesterilizationprocessTRAINING,includingQMS/Auditing(ISO13485;internalauditing),GlobalRegulations(CEmarking,FDA,JPAL),Sterilization(Radiation,EthyleneOxide,Steam),RiskManagement(ISO14971)andProductSafety&EMC(theIEC60601series),includingFunctionalSafety5OURACCREDITATIONSOurwiderangeofaccreditationsincludes,amongothers:NOTIFIEDBODYforCEmarking,bothunder93/42/ECasamendedby2007/47/ECforMedicalDevicesand98/79/ECforIn-vitroDiagnosticMedicalDevicesNATIONALACCREDITATIONSincluding:UKASISO13485,CMDCASforCanada;JPALforJapan;FDAsiteinspectionsforUSA;INMETROforBrazil,KFDAtechnicaldocumentaccreditedbodyinKoreaandtheschemesforTaiwan,AustraliaandHongKongNCB(NationalCertificationBody)ANDCBTL'sALLAROUNDTHEWORLDwithintheCBSchemeAllourlaboratoriesareISO17025ACCREDITED.
YOURBENEFITSOurentirenetworkandmedicaldevicesportfoliohasbeendevelopedtobringaddedvaluetoyourbusinessandfasttrackyourmarketaccess.
Weoffer:FLEXIBILESOLUTIONSthatkeepyourbusinessinmind,puttingtestdatatowork,tograntyouaccesstomultipleapprovals,including:CB,CE,NRTL,FDA,etc.
CONVENIENTCUSTOMERINTERFACEwithanoptionofalocalkeyaccountmanager,tohandleallyourtesting,certificationandanyotherserviceneedsuniquelysuitedtoyourbusinessCOMPLETETESTINGOFYOURPRODUCTSINOURLABSinaccordancewiththecommonlyusedharmonisedstandardsandyourspecificrequirementsSUPPORTWITHCOMPLEXREGULATORYCOMPLIANCEsuchasriskmanagementrequirementsfortheMedicalDevicesDirective(MDD)andtheIn-vitroDiagnosticMedicalDevicesDirective(IVD)oraddressingriskmanagementrequirementsperISO14971OURCERTIFICATIONMARKSThankstothewiderangeofaccreditationsgained,SGScanofferyoucompletetestingandcertificationservicesfornearlyallregulatorycriteriaandmarkets.
YoucanalsoaccessSGS'sownglobalcertificationmarks.
Hereareafewexamplesofsuchmarks:SGSSystemCertificationMarkICEOFFERINGRegardlessoftheprojectsizeandnumberofmarketstargeted,SGScanimprovetheefficiencyandvalueofyouroperationbycombininginoneglobalpackagetheadvantagesofourworldwidereach,widerangeofaccreditations,resourcesandglobalexpertise.
SGSElectrical&ElectronicsCertificationMarks01206Foranindustrywheretimingiseverything,SGSoffersmedicaldevicemanufacturersagloballyintegratedsolutiontogettheirnewdevicestomarketfaster.
Whatevernewmarketsyourareplanningtoenter,wearelikelyalreadythere.
YOUAREFULLYCOVEREDTHESGSNETWORKSGSistheworld'sleadinginspection,verification,testingandcertificationcompany.
Recognizedastheglobalbenchmarkforqualityandintegrity,weemploy75,000peopleandoperateanetworkofmorethan1,500officesandlaboratoriesaroundtheworld.
Supportingorganizationslargeandsmall,fromeverystepofthesupplychain,weensurethatmedicaldeviceprojectsachievequickregulatorycompliancethattranslatesinfastermarketaccessandfasterprofitsrealization.
AsaleadingserviceproviderforthemedicaldevicesandIVDindustries,SGShasdevelopedanetworkofmedicaldevicesexpertslocatedallovertheworld.
Withknowledgeoflocalregulationsandmarketsandinstantaccesstoourglobalcapabilities,theSGSmedicaldeviceexpertinyourregionhastheone-stop-solutionforyourmedicaldevicesbusiness.
GETYOURPRODUCTTOMARKETFASTER.
WEKNOWTHEWAY7WITHYOURSGSMARKETACCESSPASSPORTCOUNTRYSGSACCREDITATIONSGSMEDICALDEVICESERVICEGLOBALUKASAccreditationforISO13485:2003,ISO9001:2008andISO14001:2004(FINAS)NCBundertheIECEECBSchemewithCBTLsaroundtheworldAllourlaboratoriesareISO17025accreditedAuditsbylocalSGSstaffCBtestresultscanbeintegratedtogainaccesstoover52countriesProductTestingforSafetyandEMCtoIEC(IEC60601andIEC61010series)EUNotifiedBodyforMDDandIVDDirectivesforalldevicesAuditsandtechnicalfilereviewsbySGSauditorsandproductexpertsProductTestingforSafetyandEMCtoENStandards(EN60601andEN61010series)USFDAAccreditedPersonProgramNRTLFDASiteInspections3rdpartydatareportreviewforFDA510(K)ProductSafetyandEMCTesting(UL61010series)CANADACMDCASRecognizedRegistrarStandardsCouncilofCanadaaccreditationAuditsbylocalSGSstaffProductSafetyandEMCTesting(CSA60601andCSA61010series)JAPANJPAL3rdPartyRecognizedCertificationBodyAuditsandtechnicalfilereviewsProductSafetyandEMCTestingBRAZILINMETRORecognizedCertificationBodyAuditsandTestingtoIECandNBRstandardsresultinginINMETROcertificationandmarkProductSafetyandEMCTestingTAIWANTechnicalCo-operationProgramme(TCP)partnerISO13485AuditstoincludeROCTaiwanrequirementsProductSafetyandEMCTestingCHINASFDARegistrationPre-evaluationwithProductSafety,PerformanceTestandEMCTestingAdministrativeProceduresHONGKONGConformityassessmentbodyundertheMedicalDeviceAdministrativeControlSystem(MDACS)AuditsandTechnicalFileReviewsProductSafetyandEMCTestingKOREAKFDADesignatedTechnicalFileReviewBodyKFDADesignatedTrainingBodyforGMPTestingtoIECstandard(CB&KOLASreport)forKFDATrainingServicesonMedicalDeviceTechnicalFileandGMPRequirementsProductSafetyandEMCTestingSINGAPORESABaccreditationforGDPMDSAuditsofSingaporeImportersandDistributorsProductSafetyandEMCTestingAUSTRALIAListedinMutualRecognitionAgreementwithTGAAcceptanceofSGSCertificationProductSafetyandEMCTestingSGSofferscompleteglobalsolutionsformedicaldevicesandIVDmarketaccess.
CONTACTUSFormoreinformationonSGSmedicaldeviceservicesvisit:www.
sgs.
com/consumermedicaldevicesorcontactusat:ee.
global@sgs.
com8WWW.
SGS.
COMSGSGroupManagementSA–2013–Allrightsreserved–SGSisaregisteredtrademarkofSGSGroupManagementSA