ISATIFIKETHI SECOMTECH yanikezelwa iSatifikethi sokuLawulwa kweNkqubo ye-EU (MDR) ekhutshwe nguTüvsüd Süd nge-28, 2022. Ubungakanani besiqinisekiso kubandakanya: I-Digital Thermometer, Uxinzelelo lwegazi, I-infrared yendlebe, ibunzi le-Inframeter, i-Intermageral Head-Intermometer , impompo yombane impompo, impompo yendawo ye-ibele. Yenye yeenkampani zokuqala zase China ukuba zifumane isatifikethi sokuthotyelwa kwe-Ce phantsi kweemfuno ze-MDR entsha, kwaye sisiqinisekiso sokuqala se-MDR se-elektromesters, i-pumpslate ye-thermometers kunye neempompo zendle.
I-Joytech yezonyango ishishini lezonyango ligxile kwi-R & D, ukuvelisa kunye nentengiso yezixhobo zonyango ekunikezeleni izifo zempilo kunye nokunganyangeki. Ukusukela oko ukumiliselwa, inkampani ithathelwe ingqalelo njengeshishini le-Tech-tech-tech-test kunye nezamashishini eliphezulu kwi-Tech-Dech kwi-Tech-Tech kwi-Hangzhou. I-Joytech yezonyango idlulile kwi-ISO13485, i-MSSAP kunye nezinye iinkqubo zolawulo lomgangatho. Iimveliso zethu zifumene i-NMPA yasekhaya, i-US FDA, eu, eCanada CMDCAAS, eJapan PMDA kunye nezinye izinto ezitshintshwayo, kwaye zivunyiwe kwintengiso. Kwaye sifikelele ekusebenzisana phambili ngenqanaba elide kunye namashishini amaninzi adumileyo ekhaya nakwamanye amazwe.
I-EU ihamba ngokuthe ngcembe kwimarike enkulu emanyeneyo yokuphelisa izithintelo zorhwebo phakathi kwamalungu amanye, iinkonzo, imali eyinkunzi kunye neemveliso (ezinjengezixhobo zonyango). Kwicandelo lezixhobo zezonyango, iKomishini yaseYurophu iye yaqulunqa imiyalelo emithathu ye-EU yokutshintsha inkqubo yeLungu leLungu leLungu ngalinye, ukuze imigaqo ekuthengiswe kwintengiso enjalo inokulungelelaniswa.
I-EU MDR ibhekisa kuMmiselo waseburhulumenteni waseburhulumenteni (i-MDR) ekhutshwe yi-EU (i-MDR yomgaqo wesixhobo sonyango (EU) 2017/75), esekwe kwiimfuno zenqaku le-123 le-MDR. I-MDR ingene kwi-Meyi 26, 2017 kwaye ithatha indawo kaMeyi ethathe indawo yangaphambili yonyango (i-MDD 93/42 / i-EEDD) kunye ne-MeeCement Forgive (AEDD)
Xa kuthelekiswa nomyalelo wesixhobo sezonyango (i-MDR), i-MDR iyingqongwe ngakumbi malunga nolawulo lomngcipheko kwimveliso, ukusebenza kwemveliso kunye nemigangatho yokhuseleko, uvavanyo lweklinikhi, kunye nokubekwa esweni kweemveliso. Ikwangumceli mngeni omkhulu kwinkqubo yolawulo lomgangatho womenzi kunye nokusebenza kwenkqubo yemveliso.
Impumelelo ephumeleleyo yesiqinisekiso se-MDR ibonisa umgangatho ophezulu kunye nomgangatho weemveliso zonyango lwe-googlech kunye nokwamkelwa kwemarike ye-EU. I-Joytech yezonyango iya kuthatha isiqinisekiso se-MDR CE Njengethuba elitsha lophuhliso lokufikelela ngakumbi ubume beentengiso zehlabathi kwaye banegalelo kwishishini lonyango lwehlabathi.
