Joytech Medical yakapihwa EU Quality Management System Sitifiketi (MDR) yakapihwa neTüVSüD SÜD musi waKubvumbi 28, 2022. digital thermometer, blood pressure monitor, infrared ear thermometer, infrared pahuma thermometer, multifunction yehuma thermometer , yemagetsi pombi yemazamu, bhuku remazamu pombi. Iyo ndeimwe yemakambani ekutanga muChina kuwana chitupa chekuteerera cheEC pasi pemutemo mutsva weMDR zvinodiwa, uye ndiyo yekutanga MDR chitupa chemagetsi emagetsi thermometers, infrared nzeve thermometers nemapombi emazamu.
Joytech Medical ibhizimusi remudziyo wekurapa rinotarisa paR&D, kugadzira uye kutengesa kwemidziyo yekurapa yekutarisa hutano uye kutonga kwechirwere chisingaperi. Kubva payakatangwa, kambani yave ichizivikanwa senyika yepamusoro-tekinoroji bhizinesi uye yepamusoro-tech R&D pakati bhizinesi muHangzhou. Joytech Medical yakapfuura ISO13485, MDSAP uye mamwe masisitimu emhando yepamusoro. Zvigadzirwa zvedu zvakawana zvekumba NMPA, US FDA, EU CE, Canada CMDCAS, Japan PMDA uye zvimwe zvitupa uye kunyoreswa, uye zvakatenderwa kushambadzira. Uye isu tasvika kwenguva refu yehurongwa hwekushandira pamwe nemabhizinesi mazhinji ane mukurumbira kumba nekune dzimwe nyika.
EU iri kuvaka zvishoma nezvishoma kuita musika mukuru wakabatana kubvisa zvipingamupinyi zvekutengeserana pakati penyika dzenhengo uye kuona kuyerera kwemahara kwevanhu, masevhisi, mari uye zvigadzirwa (senge michina yekurapa). Mundima yezvigadzirwa zvekurapa, European Commission yakagadzira matatu eEU mirairo yekutsiva iyo yekutanga yekubvumidzwa system yenyika yega yega nhengo, kuitira kuti mirau ine chekuita nekushambadzira kwezvinhu zvakadaro ienderane.
EU MDR inoreva iyo yepamutemo Medical Device Regulation (MDR) yakapihwa neEU (Medical Device Regulation (EU) 2017/745), zvichienderana nezvinodiwa zveChinyorwa 123 cheMDR. iyo MDR yakatanga kushanda muna Chivabvu 26, 2017 uye inotsiva zviri pamutemo yaimbova Medical Device Directive (MDD 93/42/EEC) uye Active Medical Device Directive (AEDD) kubva muna Chivabvu 26, 2020, iyo Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Kuenzaniswa neMedical Device Directive (MDD), iyo MDR inonyanya kuomesera maererano nekugadzirisa njodzi yechigadzirwa, kuita kwechigadzirwa uye kuchengetedza zviyero, kuongororwa kwekiriniki, pamwe nekuchenjerera kwepamusika uye kutarisa kwezvigadzirwa. Iri zvakare dambudziko guru kune mugadziri wemhando yekutonga system uye chigadzirwa kuchengetedza kushanda.
Kubudirira kubudirira kweMDR certification kunoratidza mwero wepamusoro uye mhando yezvigadzirwa zveJoytech Medical uye kucherechedzwa kwemusika weEU. Joytech Medical ichatora MDR CE certification semukana mutsva webudiriro wekuwedzera kudzamisa musika wepasi rose marongero uye kubatsira kuindasitiri yezvekurapa yepasi rose.
