Chinatɔwo ƒe adzɔnuwɔƒe siwo tsia dzi ɖe nusiwo wotsɔna ɖoa duta ŋu — le nyaƒoɖeamenu si nɔa anyi ɖaa tso EU ƒe MDR ƒe tɔtrɔ yeyewo gbɔ, FDA ƒe ŋkuléle ɖe nu ŋu geɖe wu, kple mamalawo ƒe agbalẽdzikpɔkpɔ siwo bia tso wo si me — de ga geɖe ɖe ɖoɖo nyuiwo, dɔwɔnu siwo wɔa dɔ pɛpɛpɛ, kple dukɔwo dome ɖaseɖigbalẽwo me le ƒe ewo siwo va yi me. Nusi dona tso emee nye asi si me mama le eve: adzɔnuwo ƒe dɔwɔƒe siwo wɔa nusiwo womede vovototo wo dome o le eƒe nuwuwu ɖeka, kple OEM hadɔwɔla siwo si ŋutete le ŋutɔŋutɔ siwo wɔa ɖoɖo nyui siwo sɔ kple Ɣetoɖoƒetɔwo ƒe nubablawɔlawo le nuwuwu kemɛ.
Tsã la, ƒumeŋuɖui ƒe fli si ŋu ame ŋutɔ ƒe ŋkɔ le dodo ɖe ŋgɔ fia tiatia gbegblẽ eve dometɔ ɖeka: tsɔ ɖokuiwò na be yeawɔ nudɔdɔ gbãtɔ gã aɖe (eye nàdo gbe ɖa be yeate ŋu atsɔ nudzraɖoƒewo ayi teƒe bubu), alo nànɔ anyi ɣleti geɖe le esi nutatawo, nubablɛwo ƒe faɛlwo, alo ɖoɖo si me kɔ be nàwɔ ɖe se dzi mele asiwò o ta. Yameʋukula si ƒe MOQ mede o trɔa akɔntabubua. Le esi teƒe be nàda tsatsa le agbɔsɔsɔme ŋu la, ètsɔa duƒuƒu gbãtɔ si dzi wokpɔna ɖoa kpe nudzrala la, nuŋlɔɖiawo, kple wò asi ƒe didi dzi.
Ame yeye tiatia na ƒumeŋuɖui alo dɔwɔnuwo mele abe ɔfis dzralawo ƒe tɔtrɔ ene o. Asixɔxɔ dzi ɖuɖu ate ŋu atrɔ azu sedziwɔwɔ ƒe taɖuame, megbenyawo ƒe ʋuʋu, alo kakaɖedzi si woƒo kple wò kɔdzi ƒe akɔntabubuwo.Wotu mɔfiame sia na xexeame katã ƒe mamalawo kple kɔdzi ƒe nuƒleha siwo w