202306/21
Needleless Corporation Successfully Renews BSI ISO 13485:2016 Certification — Global Recognition of Quality Management System
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.
