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, blɔd prɛshɔn monitɔr, infrared ia tɛmɔmɔta, infrarɛd fɔrɛst tɛmɔmɔta, multifunction fɔrɛst tɛmɔmɔta , ilɛktrik brɔst pɔmp, manual brɔst pɔmp. Na wan pan di fɔs kɔmni dɛm na Chaina fɔ gɛt di CE kɔmplians sɛtifiket ɔnda di nyu rigyuleshɔn MDR rikwaymɛnt dɛm, ɛn na di fɔs MDR sɛtifiket fɔ domestik ilɛktronik tɛmɔmɔta, infrarɛd ia tɛmɔmɔta ɛn brɔst pɔmp.
Joytech Medical na wan mɛdikal divays ɛntapraiz we de pe atɛnshɔn pan di R&D, prodakshɔn ɛn sɛl fɔ mɛdikal divays fɔ wɛlbɔdi monitarin ɛn krɛse sik manejmɛnt. 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 Medical dɔn pas ISO13485, MDSAP ɛn ɔda kwaliti manejmɛnt sistem dɛn. Wi prɔdak dɛn dɔn gɛt domestik NMPA, US FDA, EU CE, Kanada CMDCAS, Japan PMDA ɛn ɔda sɛtifiket ɛn rɛjista, 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 (lɛk mɛdikal divays dɛn) fri flɔ. 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 makɛt fɔ dɛn kayn prɔdak dɛn de go ebul fɔ mek wanwɔd.
Di EU MDR de tɔk bɔt di ɔfishal Mɛdikal Divays Rɛgyuleshɔn (MDR) we di EU dɔn gi (Mɛdikal Divays Rɛgyuleshɔn (EU) 2017/745), we dɛn bays pan wetin Atikul 123 na di MDR se. di MDR bin bigin fɔ wok pan May 26, 2017 ɛn ɔfishal wan i tek ples fɔ di fɔs Mɛdikal Divays Dairekt (MDD 93/42/EEC) ɛn di Aktiv Mɛdikal Divays Dairekt (AEDD) as of May 26, 2020 , di Implantable Mɛdikal Divays Dairekt (AIMDD 90/385/EEC).
We yu kɔmpia am wit di Mɛdikal Divays Dairekt (MDD), di MDR strɛng mɔ pan di prɔdak risk manejmɛnt, prodak pefɔmɛns ɛn sefty standad, klinik ɛvalueshɔn, ɛn bak post-maket vigilɛns ɛn supavayshɔn fɔ prodak. I de bak bi big chalenj to di manifakta in kwaliti manejmɛnt sistɛm ɛn prodak seft ɛfifishins.
Di saksesful achivmɛnt fɔ MDR sɛtifikeshɔn de sho di ay standad ɛn kwaliti fɔ Joytech Medical in prɔdak dɛm ɛn di rɛkɔgnishɔn fɔ di EU makit. Joytech Medical go tek di MDR CE sɛtifiket as nyu divɛlɔpmɛnt chans fɔ dip mɔ di glob ɔl makɛt layout ɛn kɔntribyut to di glob ɔl mɛdikal industri.
