REQUEST FOR PROPOSAL - (EN) ISO 13485:2016Please enable JavaScript in your browser to complete this form.1. IMPORTANT INFORMATION - Step 1 of 6Request to fill up the below form with actual information to generate a cost estimate and timeline.NEXTCompany Name *Address *Address Line 1Address Line 2CityState / Province / RegionPostal CodeAfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBolivia (Plurinational State of)Bonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCabo VerdeCambodiaCameroonCanadaCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo (Democratic Republic of the)Cook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Kingdom of)EthiopiaFalkland Islands (Malvinas)Faroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIran (Islamic Republic of)IraqIreland (Republic of)Isle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea (Democratic People's Republic of)Korea (Republic of)KosovoKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesia (Federated States of)Moldova (Republic of)MonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth Macedonia (Republic of)Northern Mariana IslandsNorwayOmanPakistanPalauPalestine (State of)PanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussian FederationRwandaRéunionSaint BarthélemySaint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint Maarten (Dutch part)SlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwedenSwitzerlandSyrian Arab RepublicTaiwan, Republic of ChinaTajikistanTanzania (United Republic of)ThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkmenistanTurks and Caicos IslandsTuvaluTürkiyeUgandaUkraineUnited Arab EmiratesUnited Kingdom of Great Britain and Northern IrelandUnited States Minor Outlying IslandsUnited States of AmericaUruguayUzbekistanVanuatuVatican City StateVenezuela (Bolivarian Republic of)VietnamVirgin Islands (British)Virgin Islands (U.S.)Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland IslandsCountryWebsite / URLBACKNEXTCertification Body Already SelectedNot SelectedAlready selected, please mention ethe CB nameScope of Work (Company) *SelectDesign, Development, Manufacture and DistributionManufacture and DistributionDistributionManufacturing Sales and ServiceScope of Work (Consultants) *SelectGuidance, Documentation and Internal Audit SupportGuidance, Documentation & Implementation SupportGuidance, Documentation, Implementation Guidance, Internal & External Audit SupportBACKNEXTDepartments Currently Functioning *Production / Software DevelopmentHuman ResourcesPurchaseMaintenanceQuality ControlQuality Assurance / RegulatoryDesign & DevelopmentMarketing & Compliant HandlingSales / DistributionInstallation & ServiceServicingStores / InventoryResearch & DevelopmentClinical Packing & DispatchMore departments, not listed aboveNumber of Employees *Select1-55-105-1015-2525-5050-100100-200200-400Person / Employee to Coordinate with Consultants *NoYesDocumentation & Device Knowledge of the above Person /Employee *SelectGoodAveragePoorBACKNEXTCritical Process Outsourced *No activities Outsourced.DesignManufacturingSterilizationInstallation & ServicingTestingPrototypingComponent ManufacturingClean Room Manufacturing *NoYesSterilization Process Involved in the manufacturing. *NoYesOutsourcedNextSubmitter Name *Designation / Job Title *Phone *Email *BACKSubmit
