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ISO 13485 - Demonstrating a Commitment to Quality & Customer Satisfaction

Organizations Certified to ISO 13485 can find commitment to quality & satisfaction in the medical device industry framework. This standard ensures their product to meet stakeholderu2019s requirement, while also benefited with efficacy and other safety needs

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ISO 13485 - Demonstrating a Commitment to Quality & Customer Satisfaction

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  1. ISO13485 CERTIFICATION MedicalDevicesQualityManagementSystem AscentEMIRATES FZLLC

  2. WHATISISO13485 CERTIFICATION IN UAE? ISO13485Certificationisaninternationalstandard proposedfordeployingaQualityManagement Systemforthemedicaldevicemanufacturing industriesintheUAE.Therealityofthisstandardisto demonstratetheir(manufacturers’)abilitiestoensure thequality,safety,andreliabilityoftheirproducts,as wellasmeetallapplicableregulatoryrequirements.

  3. OBJECTIVESOFISO13485 CERTIFICATION TheobjectiveofISO13485certificationistoconfirmthatmedicaldevice manufacturers have established and executed a Quality Management System(QMS)thatmeetsregulatoryISO13485requirementsandthatis focusedonthesafetyandeffectivenessoftheirproducts. Thiscertificationhelpsmedicaldevicemanufacturerstodemonstratetheir commitment to providing products that meet customer and regulatory requirements, as well as enhancing customer satisfaction. As per the standard, each manufacturer should produce the most profitable and productivemedicalequipment.

  4. WhatDecidestheISO13485CertificationCost? ISO13485CertificationCostisimpactedbyavarietyof factorssuchas: Thesizeoftheorganization Thescopeofcertification Thecomplexityoftheprocesses thegeographicallocation(costsmayvarybetween countriesandregions) ASCENTEMIRATES

  5. WHICHORGANIZATIONSREQUIRE ISO13485? Organizationsthatdesign,develop,manufacture,and/or distributemedicaldevicesmayrequireISO13485 certificationinUAEsuchas: MedicalDeviceManufacturers MedicalDeviceDistributors MedicalDeviceContractManufacturers MedicalDeviceComponentManufacturers.

  6. BENEFITSOFISO13485CERTIFICATION HereisthelistofbenefitscomingfromtheISO13485 certificate: ImprovedQualityofproductsandservices Increasedcustomersatisfaction Costsavings Increased efficiency Enhancedbrandimage

  7. STEPSTOGETISO13485CERTIFICATION Conductgapanalysis Providingtrainingtomanagementandemployeesfor achievingISO13485certificate Guidanceregardingdocumentationandimplementationof MDQMS Guidanceonconductingrisk/opportunityassessment Aninternalauditbytheconsultant Externalauditbycertifyingbody ClosureofconformitiesasperISO13485standard Issuingcertificate

  8. CONTACT US AscentEMIRATEScanhelpyougetintoISO 13485CertificationinUAE,Oman,&Saudi Arabia,today! So, connect with our expert advisory team @uaeoffice@ascentworld.comtolearnmore. Dial:+971-4-4558490toavailBestOffers. Office1401,BoulevardPlazaTower1,EMAARBoulevard,Near“The DubaiMall”,Opp“BurjKhalifa”,DowntownDubai,UAE

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