Ua hāʻawi ʻia ʻo Joytech Medical i ka EU Quality Management System Certificate (MDR) i hoʻopuka ʻia e TüVSüD SÜD ma ʻApelila 28, 2022. Aia ka laulā o ka hōʻoia: ana wela kikohoʻe, nānā i ke koko, ka wela wela o ka pepeiao infrared, wela wela lae infrared, wela wela lae multifunction , pamu umauma uila, pamu umauma lima. ʻO ia kekahi o nā hui mua loa ma Kina e kiʻ
ʻO Joytech Medical kahi ʻoihana lāʻau lapaʻau e nānā ana i ka R&D, ka hana ʻana a me ke kūʻai ʻana i nā mea lapaʻau no ka nānā ʻana i ke olakino a me ka hoʻokele maʻi maʻi. Mai kona hoʻokumu ʻana, ua ʻike ʻia ka hui ma ke ʻano he ʻoihana ʻenehana kiʻekiʻe a me kahi ʻoihana kikowaena R&D kiʻekiʻe ma Hangzhou. Ua hala ʻo Joytech Medical i ka ISO13485, MDSAP a me nā ʻōnaehana hoʻokele maikaʻi. Ua loaʻa i kā mākou huahana nā NMPA home, U� FDA, EU CE, Canada CMDCAS, Japan PMDA a me nā palapala hōʻoia a me nā hoʻopaʻa inoa, a ua ʻae ʻia no ke kūʻai aku. A ua hōʻea m
Ke kūkulu mālie nei ka EU i kahi mākeke hui nui e hoʻopau i nā pale kālepa ma waena o nā moku'āina lālā a hōʻoia i ka holo manuahi o nā kānaka, nā lawelawe, ke
ʻO ka EU MDR e pili ana i ka mana o ka Medical Device Regulation (MDR) i hoʻopuka ʻia e ka EU (Medical Device Regulation (EU) 2017/745), e pili ana i nā koi o ka Paukū 123 o ka MDR. Ua hoʻokomo ka MDR i ka mana ma Mei 26, 2017 a hoʻololi hou i ka Medical Device Directive (MDD 93/42/EEC) a me ka Active Medical Device Directive (AEDD) mai Mei 26, 2020, ka Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Ke hoʻohālikelike ʻia i ka Medical Device Directive (MDD), �
ʻO ka holomua o ka hōʻoia MDR e hōʻike ana i ke kūlana kiʻekiʻe a me ka maikaʻi o nā huahana Joytech Medical a me ka ʻike ʻia o ka mākeke EU. E lawe ʻo Joytech Medical i ka palapala hōʻoia MDR CE ma ke ʻano he manawa hoʻomohala hou e hoʻonui hou i ka hoʻolālā mākeke honua a hāʻawi i ka ʻoihana olakino honua.
