Enyere Joytech Medical asambodo EU Quality Management System Certificate (MDR) nke TüVSüD SÜD nyere na Eprel 28, 2022. Oke asambodo gụnyere: temometa dijitalụ, nyocha ọbara mgbali elu, temometa ntị infrared, temometa ọkpọiso infrared, temometa ọkpọiso multifunction , mgbapụta ara eletrik, mgbapụta ara ntuziaka.Ọ bụ otu n'ime ụlọ ọrụ izizi na China iji nweta asambodo nnabata CE n'okpuru iwu ọhụrụ MDR chọrọ, yana asambodo MDR izizi maka igwe eletrọnịkị ụlọ, temometa nti infrared na nfuli ara.
Joytech Medical bụ ụlọ ọrụ ngwaọrụ ahụike na-elekwasị anya na R&D, mmepụta na ire ngwaọrụ ahụike maka nlekota ahụike yana njikwa ọrịa na-adịghị ala ala.Kemgbe e guzobere ya, a matala ụlọ ọrụ ahụ dị ka ụlọ ọrụ teknụzụ dị elu nke mba yana ụlọ ọrụ R&D dị elu na Hangzhou.Joytech Medical agafeela ISO13485, MDSAP na sistemụ njikwa mma ndị ọzọ.Ngwaahịa anyị enwetala NMPA ụlọ, US FDA, EU CE, Canada CMDASs, Japan PMDA na asambodo na ndebanye aha ndị ọzọ, ma akwadoro maka ire ahịa.Na anyị erutela ogologo oge strategic imekọ ihe ọnụ na ọtụtụ ama ụlọ ọrụ n'ụlọ na ná mba ọzọ.
EU ji nwayọọ nwayọọ na-ewulite n'ime nnukwu ahịa dị n'otu iji kpochapụ ihe mgbochi azụmahịa n'etiti mba ndị otu ma hụ na ndị mmadụ, ọrụ, isi obodo na ngwaahịa (dị ka ngwaọrụ ahụike).N'ihe gbasara ngwaọrụ ahụike, European Commission ewepụtala ntuziaka EU atọ iji dochie usoro nzere izizi nke obodo ọ bụla, ka e wee kwekọọ n'iwu gbasara ire ngwaahịa ndị dị otú ahụ.
EU MDR na-ezo aka na Iwu Ngwaọrụ Ahụike gọọmentị (MDR) nke EU (EU) 2017/745 nyere, dabere na ihe achọrọ nke Nkeji edemede 123 nke MDR.MDR batara n'ọrụ na Mee 26, 2017 wee dochie anya ntuziaka ngwaọrụ ahụike mbụ (MDD 93/42/EEC) na ntuziaka ngwaọrụ ahụike na-arụ ọrụ (AEDD) dịka nke Mee 26, 2020, ntuziaka ngwaọrụ ahụike etinyere (AIMDD 90). /385/EC).
Tụnyere ntuziaka ngwaọrụ ahụike (MDD), MDR siri ike karịa n'ihe gbasara njikwa ihe egwu ngwaahịa, arụmọrụ ngwaahịa na ụkpụrụ nchekwa, nyocha ụlọ ọgwụ, yana ịmụrụ anya mgbe ahịa na nlekọta ngwaahịa.Ọ bụkwa nnukwu ihe ịma aka maka sistemu njikwa ogo nke onye nrụpụta yana arụmọrụ nchekwa ngwaahịa.
Mmezu nke ọma nke asambodo MDR na-egosi ọkwa dị elu na ịdị mma nke ngwaahịa Joytech Medical yana nnabata nke ahịa EU.Joytech Medical ga-ewere asambodo MDR CE dị ka ohere mmepe ọhụrụ iji mee ka nhazi ahịa zuru ụwa ọnụ dịkwuo omimi ma tinye aka na ụlọ ọrụ ahụike ụwa.
