Maytech yubuvuzi yahawe icyemezo cya sisitemu yo gucunga ubuziranenge bwa EU (MDR) yatanzwe na Tüvüd Süd ku ya 28 Mata 2022. Urugero rw'icyemezo rurimo: Tormometero ya digitale, Ikirangantego cyamaraso, Amatwi ya Infrared Thermometero, incamake ya infrared thermometero, umuyoboro mu misozi mirema , pompe yamashanyarazi, pompe y'intoki. Nimwe mu masosiyete asanzwe mu Bushinwa kugirango abone icyemezo cya CE ikurikizwa amabwiriza mashya ya MDR, kandi ni icyemezo cya mbere cya MDR cyo gukora ibikoresho bya elegitoroniki yo mu rugo, inkware ya inkera na pompe.
JUESHECH Ubuvuzi nigikoresho cyibikoresho byubuvuzi byibanda kuri R & D, umusaruro no kugurisha ibikoresho byubuvuzi kubikoresho byo gukurikirana ubuzima no gucunga indwara zidakira. Kuva hashyirwaho ibigo byayo, isosiyete yamenyekanye nk'ikigo cy'imikino yo mu rwego rwo hejuru ndetse n'inzego z'ikoranabuhanga muri tekinoroji ya R & D muri Hangzhou. Joytech Ubuvuzi bwararengaga Iso13485, MDSAP nandi sisitemu yo gucunga ubuziranenge. Ibicuruzwa byacu byabonye Domeric NMPA, Amerika IC, EU, Kanada CMDCas, Ubuyapani Pmda nizindi nyandiko no kwiyandikisha, kandi byemejwe kugirango mpingere. Tumaze kugera ku bufatanye bw'igihe kirekire hamwe nimishinga myinshi izwi murugo no mumahanga.
Ubumwe bw'ibihugu by'Uburayi bugenda bwiyongera buhoro buhoro mu Isoko rinini rihuriweho kugira ngo rikureho inzitizi z'ubucuruzi hagati y'ibihugu bigize uyu muryango no kwemeza ko abantu batemba, imari n'ibicuruzwa n'ibicuruzwa (nk'ibikoresho by'ubuvuzi). Mu rwego rw'ibikoresho by'ubuvuzi, Komisiyo y'Uburayi yashyizeho amabwiriza atatu yo gusimbuza gahunda yemewe ya buri muntu kubyemererwa na buri gihugu cyagize, bityo amabwiriza ajyanye no kwamamaza ibikomoka ku bicuruzwa arashobora guhuzwa.
Eu MDR ivuga amabwiriza yemewe yubuvuzi (MDR) yatanzwe na EU (EU) 2017/745), ashingiye kubisabwa ningingo ya 123 ya MDR. MDR yinjiye mu bikorwa ku ya 26 Gicurasi 2017 kandi asimbuye kumugaragaro ibikoresho byahoze mu buvuzi (MDD 93/42 / EEC ikora amabwiriza y'ubuvuzi (AEDD) guhera ku ya 26 Gicurasi 2020/385/385 / EEC).
Ugereranije nubuyobozi bwibikoresho byubuvuzi (MDD), MDR ni ingenzi mu micungire y'ibicuruzwa, imikorere y'imikorere n'imikorere y'umutekano, isuzuma ry'umutekano, isuzuma ry'amavuriro, ndetse no kuba maso no kugenzura ibicuruzwa bya nyuma. Ni ikibazo gikomeye kuri sisitemu yo gucunga ubuziranenge bwumubiri no gukora umutekano wibicuruzwa.
Ibyagezweho byagezweho kuri gahunda ya MDR byerekana uburyo bwo hejuru kandi bwiza bwibicuruzwa byibicuruzwa bya Joytech no kumenya isoko rya EU. Ubuvuzi bwa Joytech buzafata icyemezo cya MDR CE nkumuheto mushya witerambere kugirango aruruze uburyo bwo ku isi yose kandi bitanga umusanzu mubikorwa byubuvuzi bwisi yose.
