News

NeedlelessCorporationannouncedthatithassuccessfullypassedthelatestauditandcertificationoftheQualityManagementSystemforMedicalDevices(QMS)conductedbytheTaiwanFoodandDrugAdministration(TFDA)undertheMinistryofHealthandWelfare.ThenewQMSCertificate,numberedQMS1421,isvaliduntilAugust26,2028.Thisrenewalnotonlymaintainsthecompany’sexistingmanufacturingqualityassurancesystembutalsosignifiesamajorexpansioninitsscopeofdesignandmanufacturing,underscoringNeedlelessCorporation’scontinuouscommitmenttotechnicalexcellenceandregulatorycomplianceattheinternationallevel.ExpandedCertificationScopeDemonstratesDiversifiedManufacturingCapabilitiesTheexpandedscopeofthenewQMSCertificatecoversthefollowingproductcategories:IntravascularAdministrationSet(Sterile):Design,Manufacture,Packaging,Labeling,andFinalReleaseAutomatedBloodCellSeparator(Sterile):Manufacture,Packaging,andLabelingLaserSurgicalInstrumentforGeneral,PlasticSurgery,andDermatology(Sterile):Manufacture,Packaging,andLabelingUrologicalCatheterAdapter(Sterile):Design,Manufacture,Packaging,Labeling,andFinalReleaseFeedingBag:Design,Manufacture,Packaging,Labeling,andFinalReleaseTheexpandedcertificationscopedemonstratesthatNeedlelessCorporationnotonlypossessesstablemanufacturingcapabilitiesinmedicaldisposablesbuthasalsosuccessfullyadvancedintoclinicalandsurgicaldeviceapplications.Thisachievementhighlightsthecompany’sR&Dandqualityteams’abilitytomanageamulti-productportfoliounderanintegratedandcompliantqualitymanagementframework.AchievedThroughRigorousAudits,DemonstratinganExcellentQualitySystemTheQMSCertificatewasissuedbytheTaiwanFoodandDrugAdministration(TFDA)undertheMinistryofHealthandWelfare,inaccordancewiththeMedicalDeviceActandtheRegulationsonMedicalDeviceQualityManagementSystems,basedonISO13485:2016.Thecertificationprocessrequiredacomprehensiveon-siteauditanddocumentreview,coveringdesigncontrol,processvalidation,riskmanagement,finalrelease,traceability,andnonconformityhandling—makingitoneofthemostrigorousandchallengingqualitysystemassessmentsinthemedicaldeviceindustry.PassingallaudititemsinasinglereviewdemonstratesthatNeedlelessCorporation’sinternalQMSoperateswithexceptionalrigorandcontinuestocomplywithinternationalstandardsformedicaldevicemanufacturing.DrivenbyInternationalStandards,AdvancingSteadilyTowardtheGlobalMarketTheexpandedQMScertificationscopemarksNeedlelessCorporation’sofficialqualificationtodesignandmanufacturemultiplecategoriesofmedicaldevices,establishingastrongqualityfoundationforfutureglobalexpansionintomarketssuchasASEAN,Europe,andtheMiddleEast.ThecompanywillcontinuetoenhanceitsqualitymanagementsysteminaccordancewithISO13485:2016andTFDAmedicaldeviceregulations,drivingcontinuousimprovementandrisk-basedmanagementtoensurethateveryproductreleasedmeetsthehigheststandardsofsafetyandperformance. 

Source:https://www.ctee.com.tw/news/20250820701224-430503?utm=copy_link  NeedlelessShowcasesAdvancedManufacturingCapacity,PartneringwithInventectoDriveAI-EnabledSmartInfusionSystemDeploymentatChiMeiHospitalInamajorsteptowardadvancingdigitaltransformationinclinicalcare,NeedlelessCorporation,aleadingTaiwanesemanufacturerofmedicalinfusionconsumables,announceditscollaborationwithInventecCorporationtosupportthelarge-scaleimplementationoftheSmartMedInfusionSystematChiMeiMedicalCenter.Theprojectincludesthedeploymentofmorethan1,000smartinfusionpumpsacrossChiMei’sthreecampuses—Yongkang,Liouying,andChiali—markingthefirsthospitalnetworkinsouthernTaiwantoachieveafullyintegrated,closed-loopmedicationadministrationsystem.RobustManufacturingCapabilitiesSupportingNationwideSmartInfusionExpansionAsthecoremanufacturingpartneroftheSmartMedInfusionSystem,Needlelesshaslongspecializedinhigh-qualityinfusiontechnologies,operatingautomatedproductionlinesunderastringentISO13485qualitymanagementsystem.Thesmartinfusionkits,connectiontubing,andsafetylockinginterfacesrequiredforthisdeploymentwerealldesignedandmanufacturedbyNeedleless,withongoingoptimizationbasedonclinicalfeedbacktoensurereliabilityandpatientsafetythroughoutthesystem.NeedlelessemphasizedthatthesuccessofsmarthealthcaredependsnotonlyonAIalgorithmsanddigitalintegration,butalsoonthereliabilityofphysicalcomponents.Throughcomprehensivequalitytraceabilityandethyleneoxide(EO)sterilizationcontrol,thecompanyensuresthateverybatchofconsumablesmeetsinternationalmedicaldevicestandards—formingasolidfoundationforAI-enabledmedicalsystems.DeepCollaboration:AdvancingAIandInfusionConsumablesinSyncInventec’sSmartMedInfusionSysteminterfacesdirectlywithhospitalHISsystems,verifyingpatientwristbandsandmedicationorderstominimizemedicationerrors.Real-timeinfusionstatusandalertsaresynchronizedbacktothenursingsystem,establishingacompleteclosed-loopmedicationrecord.Fromtheearlydesignphase,NeedlelessandInventecjointlyoptimizedhardware-softwareintegration—coveringconnectioninterfaces,flow-sensingaccuracy,andsafetyvalvedesign—toachieveseamlesssynergybetweenAIintelligenceandphysicalinfusionprecision.AspokespersonfromNeedleless’ noted:“AI-drivensmarthealthcarereliesontheprecisecontrolofphysicalinfusionflow.WithoutsynchronizeddevelopmentbetweenAIsystemsandinfusionconsumables,trueclosed-loopsafetycannotbeachieved.OurcollaborationwithInventecensuresthathardwaredesignevolvesalongsideAIalgorithms,allowingbothtoadvanceinharmony.”ChiMeiHospitalSetsaNewBenchmarkforSmartMedicationSafetyWithInventecprovidingcomprehensivetrainingandon-sitetechnicalsupport,ChiMeiHospitalsuccessfullyintegratedtheSmartMedInfusionSystemintodailyclinicaloperations.Thehospitalreportedsignificantimprovementsinmedicationsafety,nursingefficiency,anddataaccuracy,underscoringthesystem’simpactonsmarthealthcaredeliveryandpatient-centeredcare.Conclusion:BuildingtheHardwareFoundationforAI-DrivenHealthcareAsAIcontinuestoshapethefutureofmedicaltechnology,NeedlelessremainscommittedtoenhancingitsR&Dcapacityforsmartinfusionconsumablesanddeepeningcross-sectorcollaborationswithsystemintegratorsandhealthcareinstitutions.TheChiMeiHospitalimplementationnotonlydemonstratesthematurityofTaiwan’ssmarthealthcareecosystembutalsoreinforcesNeedleless’leadershipinqualitymanufacturing,clinicalinsight,andintegratedinnovation. 

Source:https://money.udn.com/money/story/5612/8703808NeedlelessCorporation’sself-developedandmanufacturedinfusionpumpserieshavebeenofficiallyadoptedinLuodongPoh-AiHospital,incollaborationwithIngrasys’“SmartMedInfusionSystem,”makingitthefirstmedicalinstitutionineasternTaiwantofullyimplementaconnectedsmartinfusionsolution.Dr.Wen-BinWang,SuperintendentofLuodongPoh-AiHospital,statedthatduringthesystemimplementation,Ingrasysdemonstratedoutstandingsoftware-hardwareintegrationandservicecapabilities,flexiblytailoringthesystemtomeetclinicalneeds.ThehospitalwillcontinuetocollaboratecloselywithIngrasystoexploremoresmarthealthcareapplicationsandfurtherenhancepatientsafetyandmedicalquality.ThevariousinfusionsetsdesignedforusewiththeSmartMedInfusionPumpsarealldevelopedandmanufacturedbyNeedleless,includingstandardinfusionsets,volumetricdripchambersets,NTGmedicationinfusionsets,light-shieldeddrugsets,andthenewlylaunchedtransfusioninfusionset.AllproductsareproudlydevelopedandmanufacturedinTaiwan,ensuringbothqualityassuranceandreliablesupply.Goingforward,Needlelessplanstoexpanditsproductlinetoincludesyringeandfeedingpumps,integratingalldevicedataontoaunifiedplatform.Thiswillcreateasafer,smarter,andmoreefficientinfusionenvironment,furthercontributingtotheadvancementofsmarthealthcareinTaiwan.Undertraditionalinfusionworkflows,nursesmustrelyonmanualsettingsandverificationsteps,yethumanerrorcanstilloccur.TheSmartMedInfusionSystem,poweredbyproprietarysmarthealthcaretechnology,enablesautomaticorderdownload,errorprevention,real-timemonitoring,anomalyalerts,andautomaticdocumentation—significantlyimprovingbothsafetyandclinicalefficiency.

 NeedlelessPartnersandTaipeiMedicalUniversityHealthcareSystemAI-DrivenInfusionAdvancementShowcasesTaiwan’sIndependentR&DandManufacturingPower TheTaipeiMedicalUniversity(TMU)HealthcareSystemhasfullyimplementedthe“SmartMedInfusionSystem”developedbyIngrasys,becomingTaiwan’sfirstmedicalnetworktoadoptafullyconnected,prescription-linkedsmartinfusionsolution.ThesystemintegratesNeedleless’shigh-qualityinfusionsetstocreateanintelligent,closed-loopmedicationadministrationplatformthatenhancesbothpatientsafetyandclinicalefficiency. TheTMUhealthcarenetwork,comprisingTMUHospital,WanFangHospital,ShuangHoHospital,andtheNewPeople’sHospital,hasdeployed1,080smartinfusionpumps.FullyintegratedwithitsHIS3.0system,thesolutionautomaticallycross-verifiespatient,prescription,andmedicationdatawhileauto-configuringinfusionparameters.Withinthefirstthreemonthsofoperation,thesystemsuccessfullyintercepted136potentialnearmisses—achievinga0.44%errorpreventionrate—demonstratingitsoutstandingcapabilityinsafeguardingpatientsafety. AsacoremanufacturingpartnerintheSmartMedInfusionSystem,Needlelessisresponsibleforthedesignandproductionofmultiplesmart-connectedinfusionsetsunderISO13485-compliantprocesses.TheChairmanofNeedlelessstated,“TheadvancementofsmarthealthcarereliesnotonlyonAIandsoftware,butequallyoninnovationincriticalinfusionhardware.Needlelesshaslongbeendedicatedtoadvancinginfusiontechnologiesandsmartmanufacturing,andwillcontinuetocollaboratewithIngrasysandhospitalstoacceleratethereal-worldapplicationofintelligentmedicalsolutions.” Throughthiscollaboration,Needlelessdemonstratesitsrobustmanufacturingcapacityandexpertiseinmedicaldeviceintegration,markingamilestoneinTaiwan’sadvancementtowardindependentlydevelopedsmarthealthcaretechnologies.Movingforward,Needlelesswillcontinueexpandingitspresenceinintelligentinfusionanddigitalhealth,leadingthetransformationofinfusionconsumablestowardsmarter,moreconnected,andsafersolutions—servingasacornerstoneoftheAI-drivenhealthcareera.Source: https://www.ctee.com.tw/news/20241119700731-430502 

 Source:https://tw.news.yahoo.com/%E5%92%8C%E4%BF%A1%E6%B2%BB%E7%99%8C%E4%B8%AD%E5%BF%83%E9%86%AB%E9%99%A2%E9%A0%98%E5%85%88%E5%B0%8E%E5%85%A5nm%E6%8A%97%E7%99%8C%E8%97%A5%E5%93%81%E7%B2%BE%E6%BA%96%E8%AA%BF%E9%85%8D%E7%B3%BB%E7%B5%B1%E8%A8%AD%E5%82%99-022100830.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAALLM1chxOKEhf-Z9OoVJlbG22h5-k86pE9YQOFUSOxvTDsBo728h-FokWVT17A97uE7KTCuOHmsXfgkr2atE9S9H1Cs3nwGARy_pWb6NnU28W6G_iXOpbYqD2kDLHue7M-yQWnDidkBiMfNTYxFE_cjLzYBlJ1oZCTs3bGxo2EF9 NeedlelessCorporationPartnerswithKFSYSCC,MinAikTechnology,andNYCUtoDevelopanIntelligentDrugCompoundingSystem—SettingaNewBenchmarkforPatientSafetyinCancerCarePrecisionandsafetyhavealwaysbeentheultimategoalsandfundamentalstandardsofclinicaloperations.NeedlelessCorporation,apioneerinthedevelopmentandmanufacturingofClosedSystemTransferDevices(CSTD),haslongbeendedicatedtoadvancingmedicationsafetyinoncologytreatment.Inrecentyears,thecompanyhasexpandedintothefieldofdigitalandsmarthealthcare,joiningforceswithKFSYSCC,MinAikTechnology,andNationalYangMingChiaoTungUniversity(NYCU)toco-developthenext-generationNMIntelligent​DrugCompoundingSystem.Thissystemintegratesautomation,artificialintelligence,anddigitaltraceabilitytechnologiestoenabledirectlinkagebetweenphysicians’prescriptionsandautomatedcompoundingprocesses.Bysignificantlyreducingmanualoperationsandhumanerror,thesystemenhancestheprecisionandreliabilityofchemotherapypreparation,ensuringoptimaltherapeuticoutcomesandpatientsafety.Industry–Clinical–AcademicCollaborationRealizesaDigitallyControlled,Error-ReducedCompoundingProcessTheNMIntelligentDrugCompoundingSystemrepresentsadeepcollaborationbetweenindustry,medicine,andacademia,combiningclinicalexpertise,industrialengineeringcapabilities,andacademicinnovationindigitalhealth.Equippedwithautomatedopticalinspection(AOI)andreal-timeprocessmonitoring,everycompoundingstepisrecordedandverifiedforaccuracy.Alldataareautomaticallylinkedtothehospital’sElectronicMedicalRecord(EMR)system,formingacompletetraceabilitychainfromprescriptiontodrugbatchnumber,compoundingrecords,delivery,andadministration.FutureintegrationofAI-assistedprescriptionverificationwillfurtheradvancethesystemtowardcomprehensivedigitalmanagement.Needleless:DrivingtheTransformationTowardSmartandSafeHealthcareMr.Chih-WeiChien,GeneralManagerofNeedlelessCorporation,stated,“ThiscollaborationwithKFSYSCC,MinAikTechnology,andNYCUdemonstratesourstrengthandinnovationinCSTDtechnology.BycombiningtheprovensafetyofourclosedtransfersystemwithNM’sintelligentcontrol,pharmacistscannowperformdrugcompoundingmoresafelyandefficientlythaneverbefore.”Hefurtheremphasizedthatthisinitiativeisnotmerelyatechnicalupgradebutatransformationinthecultureofpatientsafety,reflectingNeedlelessCorporation’songoingcommitmenttointegratingsmartmanufacturingandsmarthealthcaretoprotectbothhealthcareworkersandpatients.ClinicalImplementationEnhancesPharmacistEfficiencyandPatientSafetyDr.Shao-ChingChiang,DeputyDirectorofthePharmacyDepartmentatKFSYSCCandAssistantProfessoratNYCU,commented,“Pharmacistshavelongbeenburdenedwithhigh-riskandrepetitivecompoundingwork.WiththeNMIntelligentCompoundingSystem,physicalandpsychologicalworkloadsaregreatlyreduced,allowingpharmaciststofocusontheirtrueexpertise—understandingpatients,validatingprescriptions,andmonitoringtreatmentoutcomes.Thissystemtrulyempowerspharmaciststodeliversafer,morepatient-centeredcare.”Mr.Hung-JenYang,COOofMinATechnology,addedthatautomationisnotintendedtoreplacepharmacistsbuttoempowerthem.Throughhuman–machinecollaboration,thesystemensuresamoreprecise,safer,andtraceabledrugcompoundingworkflow—showcasingthetangiblevalueofindustry–medical–academicintegration.EstablishingaNewStandardforTaiwan’sMedicalInnovation,ExpandingGloballyKFSYSCC,Taiwan’sonlydedicatedcancerhospital,hasmaintainedafive-yearoverallcancersurvivalrateof75%,farexceedingthenationalaverageof56%.ThesuccessfuldeploymentoftheNMIntelligentDrugCompoundingSystemmarksanewmilestoneinTaiwan’sadvancementtowardsmarthealthcare.NeedlelessCorporationplanstofurtherexpanditspartnershipswithhealthcareinstitutionsandacademicresearchcenters,promotinginternationalimplementationoftheNMsystemtobenefithospitalsandcancerpatientsworldwide—deliveringsafer,moreprecise,andmoreefficientoncologydrugmanagementsolutions.AboutNeedlelessCorporationNeedlelessCorporationspecializesinthedesignandmanufactureofClosedSystemTransferDevices(CSTD),needle-freeinfusioninterfaces,andsmartmedicationmanagementsolutions.Itsproductsarewidelyusedinoncologychemotherapy,IVtherapy,andhazardousdrugpreparation.Guidedbythecoreprinciplesofsafety,precision,andinnovation,Needlelessisdedicatedtoadvancingtheintegrationofsmarthealthcaretechnologiesandclinicalapplications,settinganewbenchmarkforpatientsafety.  

  NeedlelessCorporationSuccessfullyRenewsBSIISO13485:2016Certification—GlobalRecognitionof QualityManagementSystemNeedlelessCorporationhasbeenawardedtheISO13485:2016QualityManagementSystemCertificationbytheBritishStandardsInstitution(BSI),undercertificatenumberMD659449,validfromJuly17,2023toJuly16,2026.ThiscertificationreaffirmsNeedlelessCorporation’sfullcompliancewithinternationalmedicaldevicequalitymanagementstandards,demonstratingitsstrongcommitmenttoproductsafety,regulatorycompliance,andcontinuousimprovement.ClearCertificationScopeReinforcesCoreProductQualityAssuranceThecertificationscopeincludes:DesignandmanufactureofsterileintravascularadministrationsetDesignandmanufactureofsteriledrugtransferdeviceThisscopehighlightsNeedlelessCorporation’scorecompetenceinsterilemedicalproducts,ensuringthateverystage—fromdesignandmanufacturingtoinspectionandrelease—operatesinaccordancewithinternationalstandardsandmaintainsconsistenteffectivenessofthequalitymanagementsystem.SustainingQualityExcellenceandStrengtheningGlobalMarketPresenceSincefirstobtainingBSIcertificationin2017,NeedlelessCorporationhascontinuouslymaintainedaneffectiveISO13485system,successfullypassingmultiplesurveillanceandrecertificationaudits.Therenewedcertificationdemonstratesthecompany’smaturityandstabilityinqualitymanagementandreinforcesglobaltrustinitsmedicaldevicemanufacturingcapabilities.NeedlelessCorporationremainsdedicatedtoitsqualitystrategyofbeing“Quality-Oriented,Regulation-Driven,andCustomer-Focused,”promotingcompany-wideparticipationandrisk-basedmanagementtoensurethesafetyandreliabilityofeveryproductdeliveredworldwide.