Joytech Medical bin gɛt di EU Kwaliti Manejmɛnt Sistɛm Sɛtifiket (MDR) we Tüvsüd Süd bin gi Epril 28, 2022. Di skɔp fɔ sɛtifiket inklud: Dijital tɛmɔmɔta ., Monitor fɔ blɔd prɛshɔn ., Infrared ia tɛmɔmɔta, infrarɛd fɔrɛst tɛmɔmɔta, multifunction fɔrɛst tɛmɔmɔta , ilɛktrik brɔst pɔmp, manual brɔst pɔmp. Na wan pan di fɔs kɔmni dɛn na Chaina fɔ gɛt di CE kɔmplians sɛtifiket ɔnda di nyu rigyuleshɔn we MDR nid, ɛn na di fɔs MDR sɛtifiket fɔ domestik ilɛktronik tɛmɔmɔta, infrarɛd ia tɛmɔmɔta ɛn brɔst pɔmp.
Joytech Medical na mɛdikal divays ɛntapraiz we de pe atɛnshɔn pan di R&D, prodakshɔn ɛn sɛl fɔ mɛdikal divays fɔ wɛlbɔdi monitarin ɛn kronik sik mɛnejɛmɛnt. Frɔm we dɛn mek am, dɛn dɔn no di kɔmni as nashɔnal ay-tek ɛntapraiz ɛn ay-tek R&D sɛnta ɛntapraiz na Hangzhou. Joytech Medikal dɔn pas ISO13485, MDSAP ɛn ɔda kwaliti manejmɛnt sistem dɛn. Wi prɔdak dɛn dɔn gɛt domestik NMPA, US FDA, EU Ce, Canada CMDCAS, Japan PMDA ɛn ɔda sɛtifiket ɛn rɛjista dɛn, ɛn dɛn dɔn gri fɔ mek dɛn makɛt. Ɛn wi dɔn rich lɔng tɛm stratejik kɔpɔreshɔn wit bɔku fambul ɛntapraiz dɛn na di kɔntri ɛn ɔda kɔntri dɛn.
Di EU de bil smɔl smɔl fɔ bi wan big yunifayd makit fɔ pul di tred barɛri bitwin di Mɛmba Stet dɛn ɛn mek shɔ se pipul dɛn, savis, kapital ɛn prɔdak dɛn nɔ de flɔ fri (lɛk mɛdikal divays dɛn). Insay di fild fɔ mɛdikal divays, di Yuropian Kɔmishɔn dɔn mek tri EU dairektv fɔ riples di ɔrijinal akrediteshɔn sistɛm fɔ ɛni Mɛmba Stet, so dat di rigyuleshɔn dɛn we gɛt fɔ du wit di makɛtmɛnt fɔ dɛn kayn prɔdak dɛn de go gɛt wanwɔd.
Di EU MDR de tɔk bɔt di Ɔfishal Mɛdikal Divays Rɛgyuleshɔn (MDR) we di EU (Mɛdikal Divays Rɛgyuleshɔn (EU) 2017/745) gi, bay di tin dɛn we de na Atikul 123 na di MDR. Di MDR bin bigin fɔ wok pan May 26, 2017 ɛn ɔfishal wan tek di ples fɔ di fɔs Mɛdikal Divays Dayrɛktiv (MDD 93/42/EEC) ɛn di Aktiv Mɛdikal Divays Dayrɛktiv (AEDD) as of May 26, 2020 , di Implantable Medical Devices Directive (AIMD 90/385/EEC).
We yu kɔmpia am wit di Mɛdikal Divays Dayrɛktiv (MDD), di MDR strɛng mɔ pan di prɔdak risk manejmɛnt, di prɔdak pefɔmɛns ɛn di sef standad, klinik ɛvalueshɔn, ɛn bak di post-maket vigilɛns ɛn supavayshɔn fɔ di prɔdak dɛn. I de bak as big chalenj to di manifakta in kwaliti manejmɛnt sistem ɛn prodak sefty ɛfifishins.
Di saksesful achivmɛnt fɔ MDR sɛtifikeshɔn de sho di ay standad ɛn kwaliti fɔ Joytech Mɛdikal in prɔdak ɛn di rɛkɔgnishɔn fɔ di EU makɛt. Joytech Medical go tek di MDR CE sɛtifiket as nyu divɛlɔpmɛnt chans fɔ mek di global makɛt layout go bifo mɔ ɛn kɔntribyut to di global mɛdikal industri.
