Joytech Medical na tuʻuina atu le EU Quality Management System Certificate (MDR) na tuʻuina atu e TüVSüD SÜD i le aso 28 o Aperila, 2022. O le lautele o le tusipasi e aofia ai: fua vevela numera, siaki toto maualuga, fua vevela taliga infrared, vevela muaulu infrared, multifunction muulu fua , pamu susu eletise, pamu susu tusi. O se tasi lea o kamupani muamua i Saina na maua le tusi faamaonia o le tausisia o le CE i lalo o le tulafono faatonutonu fou MDR manaʻomia, ma o le uluai tusi MDR mo mea faʻaeletonika faʻaeletonika, faʻamalama taliga infrared ma pamu susu.
Joytech Medical o se atinaʻe masini faʻafomaʻi e taulaʻi i le R&D, gaosiga ma le faʻatau atu o masini faʻafomaʻi mo le mataʻituina o le soifua maloloina ma le puleaina o faʻamaʻi masani. Talu mai lona faʻavaeina, o le kamupani ua lauiloa o se atinaʻe faʻatekonolosi a le atunuʻu ma se atinaʻe maualuga R & D i Hangzhou. Joytech Medical ua pasia ISO13485, MDSAP ma isi faiga pulega lelei. O a matou oloa ua maua i totonu o le atunuu NMPA, US FDA, EU CE, Kanata CMDCAS, Iapani PMDA ma isi tusipasi ma resitala, ma ua faʻamaonia m.
O le EU o loʻo faasolosolo malie ona fausia i totonu o se maketi tuʻufaʻatasia tele e faʻaumatia pa puipui fefaʻatauaʻiga i le va o sui o le setete ma faʻamautinoa le saʻolotoga o tagata, auaunaga, tupe faavae ma oloa (e pei o masini faʻafomaʻi). I le tulaga o masini faʻafomaʻi, ua faʻatupuina e le Komisi Europa ni faʻatonuga se tolu a le EU e sui ai le uluai faiga faʻatagaina o sui auai taʻitasi, ina ia mafai ona faʻafetaui tulafono faatonutonu e uiga i le maketiina o ia oloa.
O le EU MDR o loʻo faʻatatau i le Tulafono Faʻatonu Faʻatekonolosi Faʻafomaʻi (MDR) na tuʻuina atu e le EU (Fomaʻi Faʻatonuga (EU) 2017/745), faʻavae i luga o manaʻoga o le Mataupu 123 o le MDR. o le MDR na amata faamamaluina i le aso 26 o Me, 2017 ma suia aloaia ai le Faʻatonuga Faʻatonu Faʻafomaʻi (MDD 93/42/EEC) ma le Active Medical Device Directive (AEDD) e pei o Me 26, 2020, le Implantable Medical Device Directive (AIMDD 90/385/EEC).
Pe a faʻatusatusa i le Medical Device Directive (MDD), o le MDR e sili atu le faʻamalosi i tulaga o le faʻatautaia o tulaga lamatia o oloa, faʻatinoga o oloa ma tulaga saogalemu, suʻesuʻega faʻapitoa, faʻapea foʻi ma le mataala ma le mataʻituina o oloa. Ose lu'itau tele fo'i ile faiga ole pulega lelei ole gaosiga ma le saogalemu ole oloa.
O le manuia o le ausia o le MDR certification o loʻo faʻaalia ai le maualuga ma le lelei o oloa a Joytech Medical ma le faʻalauiloaina o le maketi a le EU. Joytech Medical o le a ave le MDR CE faʻamaonia e avea o se avanoa fou atinaʻe e faʻalautele atili ai le faʻatulagaina o maketi o le lalolagi ma saofagā i le alamanuia faʻafomaʻi o le lalolagi.
