Joytech Medical na tuʻuina atu le EU Quality Management System Certificate (MDR) na tuʻuina atu e TüVSüD SÜD ia Aperila 28, 2022. O le lautele o le faʻamaonia e aofia ai: fua vevela numera, siaki toto maualuga, fua vevela taliga infrared, fua vevela muaulu infrared, fuala'au multifunction , 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 faʻaeletoroni 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 resitalaina, ma ua faʻamaonia mo le maketiina. Ma ua tatou ausia le galulue faatasi mo se taimi umi ma le tele o pisinisi lauiloa i le fale ma fafo.
O le EU o loʻo faasolosolo malie ona fausia i totonu o se maketi tuʻufaʻatasia tele e faʻaumatia ai pa puipui fefaʻatauaʻiga i le va o sui o le setete ma faʻamautinoa le tafe saoloto o tagata, auaunaga, tupe faavae ma oloa (e pei o masini faafomaʻi). 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 taʻitasi, ina ia mafai ai ona faʻafetaui tulafono faatonutonu e uiga i le maketiina o ia oloa.
O le EU MDR o loʻo faʻatatau i le Tulafono Faʻatonu Faʻapitoa Faʻafomaʻi (MDR) na tuʻuina atu e le EU (Medical Device Regulation (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 le Faʻatonuga Faʻatonu Faʻafomaʻi (MDD 93/42/EEC) ma le Active Medical Device Directive (AEDD) e pei o Me 26, 2020, le Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Pe a faʻatusatusa i le Medical Device Directive (MDD), o le MDR e sili atu ona faʻamalosi i tulaga o le faʻatautaia o tulaga lamatia o oloa, faʻatinoga o oloa ma tulaga saogalemu, suʻesuʻega falemaʻi, faʻapea foʻi ma le mataala ma le vaavaaiga o oloa. Ose lu'itau tele fo'i ile faiga ole pulega lelei 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 avea 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.
