Chitsimikizo cha ISO 13485 ndi Mphamvu Zapamwamba: Zopereka za FCE ku Zida Zachipatala Zopangira Aesthetic

FCEndiwonyadira kukhala ndi satifiketi ya ISO 13485, yomwe ndi yodziwika padziko lonse lapansi yoyendetsera bwino pakupanga zida zamankhwala. Satifiketi iyi ikuwonetsa kudzipereka kwathu pakukwaniritsa zofunikira pazamankhwala, kuwonetsetsa kudalirika, kutsata, komanso kuchita bwino panjira iliyonse. Kuphatikizidwa ndi chipinda chathu choyera cha Class 100,000 chamakono, tili ndi zomangamanga komanso ukadaulo wopanga zinthu zomwe zimakwaniritsa miyezo yapamwamba kwambiri yachitetezo ndi magwiridwe antchito, kuphatikiza kutsatira zomwe FDA ikufuna.

Kuyanjana ndi Like Bio: Aesthetic Device Innovation

Monga Bio, kampani yodziwika bwino pazida zamankhwala zokongoletsedwa m'manja, idafunafuna wothandizira yemwe ali ndi luso laukadaulo ndi chitukuko komanso zipinda zoyeretsera zovomerezeka za ISO13485. Kumayambiriro kwa kusaka kwawo, adazindikira FCE ngati mnzake woyenera. Monga Bio poyamba anapereka chitsanzo cha 3D cha chipangizo chawo, chomwe chinafuna kukonzanso bwino komanso kukongola.

FCE idawunikiranso mwatsatanetsatane kapangidwe kake ndikupereka malingaliro okhathamiritsa kangapo kutengera luso lathu lopanga. Kulinganiza magwiridwe antchito ndi zokongoletsa, tidagwirizana kwambiri ndi kasitomala kudzera kangapo, ndikumaliza yankho lomwe limaposa zomwe amayembekeza.

Zovuta pakufananitsa Kwamitundu Mwamakonda kwaZofunsira Zachipatala

Poganizira kukongola kwa chinthucho, Monga Bio adapempha zobiriwira ngati mtundu woyamba. Kukwaniritsa izi kunafunikira kuthana ndi zovuta zazikulu, kuphatikiza kusankha zida zoyenera, kutsimikizira kusakanikirana bwino kwa mitundu, komanso kusunga zokolola zambiri.

FCE idalimbikitsa utomoni wapulasitiki wamankhwala ophatikizika ndi zowonjezera zamtundu wazakudya kuti mukwaniritse zomwe mukufuna. Pambuyo popanga zitsanzo zoyamba, mtunduwo udasinthidwa bwino poyerekezera ndi zomwe kasitomala amakonda komanso ma swatches amtundu wokhazikika. Njira yokhwimayi idapangitsa kuti pakhale mtundu wamtundu womwe umakwaniritsa zomwe kasitomala amayembekeza.

Kugwiritsa ntchito DHR pakutsata Kutsata ndi Kutsimikizira Ubwino

Kutsata kwa ISO 13485 kumafuna zolemba mosamala komanso kutsatiridwa panthawi yonse yopanga. Ku FCE, timatsatira dongosolo lolimba la Device History Record (DHR), ndikulemba mbali zonse za kupanga, kuphatikiza manambala a batch, magawo, ndi mbiri yowongolera khalidwe. Izi zimatithandiza kutsata zolemba zopanga mpaka zaka zisanu, kuonetsetsa kuti tili ndi udindo wosayerekezeka komanso chithandizo chapambuyo pakupanga.

Kupambana Kwanthawi Yaitali Kudzera Mgwirizano

Kudzipereka kwa FCE pazabwino, kutsatira mosamalitsa miyezo ya ISO13485, komanso kuthekera kothana ndi zovuta zopanga zinthu kwadzipangira mbiri yabwino. Mgwirizano wathu ndi Like Bio wasintha kukhala mgwirizano wanthawi yayitali, ndipo makampani onsewa akupindula ndi kukula kogawana komanso ukadaulo.

Mwa kuphatikiza ukadaulo wapamwamba, machitidwe okhwima, ndi mayankho ogwirizana, FCE ikupitilizabe kuyika chizindikiro cholondola komanso chodalirika pamakampani opanga zida zamankhwala.