REQUEST FOR PROPOSAL - BIOCOMPATIBILITY TESTINGPlease enable JavaScript in your browser to complete this form.1. IMPORTANT INFORMATION - Step 1 of 6Provide the following information in order to receive a detailed biocompatibility testing proposal. Remember to fill out separate forms for each device. Remember to fill out a new form for each device you intend to test.NEXTSPONSOR COMPANY NAME *Address *Address Line 1Address Line 2CityState / Province / RegionPostal Code--- Select country ---AfghanistanAlbaniaAlgeriaAmerican 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 / URLBACKNEXTSCOPE OF SERVICESelectBiocompatablity TestingBiological EvaluationBiological Evaluation Report & Biocompatibility TestingREGULATORY REQUIRMENTUS FDAEU CE MARK / UKCA MARKOTHERSBACKNEXTName of the Medical device *Intended UseWhat is the purpose of this device?Device Risk Class *Class IClass I, FDAClass I (S/M/R)Class IIAClass II FDAClass IIBClass III (EU/FDA)Human Body Contact Duration *SelectA - Limited (< 24h)B - Prolonged (24h to 30 days)C - Long Term (> 30 days)Human Body Contact Area *SelectIntact SkinMucosal MembraneBreached or Compromised SurfaceSterility? *SterileNon SterileBACKNEXTBIOCOMPATABLITY TESTS IDENTIFIED FOR THE ABOVE DEVICESelectCytotoxicitySensitizationIntra-cutaneous / IrritationMaterial Medicated PyrogenicityAcute systemic toxicitySubacute toxicitySub-chronic toxicityImplantation EffectsHemocompatibilityGenotoxicity- Bacterial Reverse MutationGenotoxicity- Chromosomal AberrationHemolysis (Direct & Indirect Contact Method)Hemocompatibility (Partial Thromboplastin Time)Hemocompatibility (Platelets & Leucocytes)Hemocompatibility (Platelet Activation)CarcinogenicityReproductive / Developmental ToxicityBiodegradationETO ResidualsDegradation from PolymericDegradation from CeramicsDegradation of Metals and AlloysLimits of Leachable SubstancesChemical CharacterizationBACKNEXTSubmitter Name *Designation / Job Title *Phone *Email *BACKSubmit Test Data Sheet