Chithandizo cha Hometech Glown Chuma: Chitsimikizika cha MDR & FDA cha mzere wathunthu

Ndi kuchuluka kwa maulamuliro a zamankhwala apadziko lonse lapansi, makampani akumayiko aku Europe ndi America amafunikira kuti asamayesedwe osavuta, komanso kuwunika kokhazikika (kuwunika) ndi kuwunika kwa ma PMS. Pali zosiyana kwambiri pakukonzanso njira zothandizira, zoyeserera komanso zilango pakati pa US FDA ndi EU MDR / IVDR.

Kodi fda (chakudya cha US ndi mankhwala ndi mankhwala) chiyani) ?
FDA amayang'anira chitetezo ndi luso la zida zamankhwala ku United States. Zipangizo zambiri, opanga ayenera kupereka 510 (k) kutsimikizira kuti malonda awo ndi otetezeka, othandiza, komanso ofanana ndi chipangizo chovomerezedwa.

MDR (kuwongolera kwamankhwala) ?
MDR ndi lamulo la European Union ya zida zamankhwala, ndikusintha zakale zakale. Ili ndi zofunikira za stricter pakuwunika kwamankhwala, kuwonjezeka kwa msika wa post, ndi zolemba zaukadaulo kuti zitsimikizire chitetezo chambiri komanso kuwonekera.

Kuyenda zonse FDA ndi MDR ndizovuta koma zotsutsa. Ku Satach, tapanga njira yolamulira yapadziko lonse lapansi kuti tikathandize anzawo abizinesi akukwaniritsa izi molimba mtima. Kaya mukukula kwa ife kapena kulowa EU pansi pa MDR, zolembedwa zathu zovomerezeka, zolemba, ndi ukadaulo wowongolera zili pano kukuthandizani.

Wha ​ w e h rve?

Ku Satach, takhazikitsa maziko olimba owongoleredwa popatsa mphamvu mabwenzi athu padziko lonse lapansi. Joyttech wapanga zingwe zokwanira komanso patsogolo zomwe zimakwaniritsa zofunikira zapadziko lonse lapansi pamisika yamankhwala.

FDA 510 (K) chilolezo

Joyttech wakhazikitsanso kupezeka kwamphamvu pamsika wa US, wokhala ndi mizere yathu yonse yazogulitsa kale FDA ndipo adapereka mwachangu kwa okwatirana apadziko lonse lapansi. Kupanga maziko ovomerezeka awa, kukonzanso kwatsopano kwatsopano kukwaniritsa zosowa zamankhwala ndi ntchito yothandizana ndi anzanu.

Mu 2025, tidakulitsa chithunzi chathu cha FDAFEFOLIO NDI CHINSINSI CHATSOPANO:

• Magazi apamwamba opanda phokoso - oyang'anira oyang'anira - popereka kutengera kokhazikika komanso zomwe munthu wagwiritsa ntchito.

• Gigh-Derder Digital Onetors (DBP-6186 / 6286B) - yopangidwa kuti ikhale ya mkono wa mkono (40-56 cm), ndi njira za Bluetooth.

• Compressror Nebulizer (NB-1100 to NB-1103) - FDA-Yoyesedwa Pansi pa Zogulitsa Caf, Kuthandizira kupuma kodalirika kwanyumba kapena ku zipatala.

EU MDR Certification

Joytech ndi ena mwa opanga aku China kuti akwaniritse chitsimikizo cha EU MDR pansi pa malamulo atsopano. Mu Epulo 2022 , tinalandira satifiketi yathu ya MDR SÜD, kuphimba zinthu monga ma armometers oyambilira, yoyamba ndi mapampu oyambilira.

Kuyambira pamenepo, tapitiliza kukulitsa mbiri yathu ya MDR-yotsimikizika chaka chilichonse. Pofika pa Okutobala 2023 , lonse kumathamanga m'matumbo ndi ma thermometer omwe adalandira CE (MDR). Pofika pa February 2025 , gulu lathu lachinayi la zinthu zotsimikizika limaphatikizapo:

• Onse a nebulizeze

• ECG kuthamanga kwa magazi

• Zizindikiro Zofunikira Motors

• Zida zonse za Bluetooth

• Mapampu onse a m'mawere

Kukula kopitilira kumeneku kumaonetsa kudzipereka kwamphamvu kwa Joytech kuti atsatire, zatsopano zazakudya, ndi kupambana kwabwino. Mapangidwe athu athunthu, kuyezetsa, kupanga, zolemba, ndi kuwunika kwa msika ku Europe - kumakwaniritsa njira zolimbitsa thupi za ku Europe, kupangitsa kuti zitheke zambiri za ku Europe, zopatsa mphamvu zotheka kutsimikizika, kusinthana kwa EU.

Miyezo ina yoyang'anira

Njira zathu zopangira zimatsimikiziridwa pa ISO 13485 ndi MDSAP , kukwaniritsa zosowa za US, Canada, Australia, Japan, ndi Brazil.

Komanso, zinthu zosangalatsa zimagwirizananso ndi kwa ma TMA (China), rohs), ndi kufikira mwachindunji, njira zachilengedwe, komanso zolembedwa, ndi Eu.

Zomwe Zimatanthawuza kwa Anzathu？

Kugwira ntchito ndi Joytech kumatanthauza zongofuna kungoyambitsa malonda - zikutanthauza kupeza mnzake yemwe amamvetsetsa zovuta za kutsata mayiko.

V ​ ​

v Kufikira kwamisika mwachangu - ndi zida zotsimikizika zotsimikizika, mutha kuyambitsa zigawo zanu zopitilira muyeso ndi kuchedwa pang'ono.

V ​ ​

v Otsimikiziridwa bwino komanso kuwunikira mawu akuti - dongosolo lathu lantchito yatha mafotokozedwe angapo achitatu, ndipo zolemba zathu zimasungidwa nthawi zonse zojambulidwa, zikuwonetsetsa kuti kuwonekera komanso kuchita bwino.

Malingaliro:
Monga malamulo osinthika asinthidwe, tidzatero. Joyttech adadzipereka kupitilirabe paulendo wawo wapadziko lonse lapansi ndi FDA NDI MDR -kuwongolera mbali zina zamisika yosasinthika, yapamwamba kwambiri m'misika yovomerezeka.

Timagwira kale zigaweka padziko lonse lapansi, kuphatikiza North America, EU, Asia, ndi kupitirira.

Mukufuna kudziwa ngati tatsimikizika mumsika wanu?

Mukuyang'ana olclatory-on / odm yankho?

Lumikizanani ndi gulu lathu lero kuti mufufuze mwatsatanetsatane zopereka zamalonda, zolembedwa zaukadaulo, komanso njira zothetsera ntchito yanu. Ndi Joytech, kutsatira kukhala mwayi wanu wopikisana.