FCEinodada nekupihwa chitupa pasi pe ISO13485, chiyero chinozivikanwa pasi rose chemhando yekutonga masisitimu mukugadzira michina yekurapa. Ichi chitupa chinoratidza kuzvipira kwedu kuzadzisa zvinoomesesa zvinodiwa zvezvigadzirwa zvekurapa, kuve nechokwadi chekuvimbika, kurongeka, uye kugona mukuita kwese. Yakabatana neyedu-ye-iyo-inoyevedza Kirasi 100,000 imba yekuchenesa, isu tine zvivakwa uye hunyanzvi hwekugadzira zvigadzirwa zvinosangana nepamusoro-soro mwero wekuchengetedza uye kushanda, kusanganisira kutevedzera zvinodiwa neFDA.
Kudyidzana neKufanana neBio: Aesthetic Device Innovation
Kufanana neBio, kambani inoshanda nemaoko anoyevedza emidziyo yekurapa, yakatsvaga mutengesi ane huinjiniya hwakasimba uye kugona kwekusimudzira pamwe neISO13485-yakasimbiswa nzvimbo yekuchenesa. Vachangotanga kutsvaga, vakaona FCE semudiwa akakodzera. Kufanana neBio pakutanga yakapa 3D modhi yechishandiso chavo, chaida zvese zvinoshanda uye zvekunatsiridza.
FCE yakaita ongororo yakazara yedhizaini uye yakakurudzira akawanda optimizations zvichienderana neruzivo rwedu rwakakura rwekugadzira. Kuenzanisa mashandiro ehunyanzvi uye zvinoyevedza zvinodiwa, takabatana zvakanyanya nemutengi kuburikidza nekudzokorora kwakati wandei, tichizopedzisa mhinduro yakapfuura zvavaitarisira.
Matambudziko muCustom Colour Matching yeMedical Applications
Tichifunga nezve aesthetic chimiro chechigadzirwa, SaBio akakumbira girini seyekutanga ruvara. Kuita izvi kwaida kukunda matambudziko akakosha, anosanganisira kusarudza zvinhu zvakakodzera, kuve nechokwadi chekusanganiswa kwemavara, uye kuchengetedza goho rakakura rekugadzira.
FCE yakakurudzira zvekurapa-giredhi epurasitiki resin akasanganiswa nekudya-akachengeteka mavara ekuwedzera kuti uwane mhedzisiro yaunoda. Mushure mekugadzira sampuli dzekutanga, ruvara rwakagadziridzwa zvakanaka kuburikidza nekuenzanisa nezvaidiwa nemutengi uye neakamisikidzwa mavara swatches. Iyi nzira yakaoma yakakonzera kuumbwa kwemavara echinyakare aizadzisa zvinotarisirwa nemutengi.
Kushandisa DHR yeTraceability uye Hunhu Simbiso
ISO13485 kuteedzera kunoda hunyanzvi zvinyorwa uye kuteedzera mukati mekugadzira maitiro. PaFCE, tinonamatira kune yakasimba Device History Record (DHR) manejimendi system, inonyora zvese zvekugadzirwa, kusanganisira nhamba dzebatch, paramita, uye marekodhi emhando yekudzora. Izvi zvinoita kuti tikwanise kutsvaga marekodhi ekugadzira kweanosvika makore mashanu, tichiona kuzvidavirira kusingaenzaniswi uye kutsigirwa kwemashure ekugadzirwa.
Kubudirira Kwenguva Yakareba Kuburikidza Nekubatana
Kuzvipira kweFCE kumhando, kuomerera ku ISO13485 zviyero, uye kugona kugadzirisa matambudziko ekugadzira zvakatipa mukurumbira. Kudyidzana kwedu neKufanana neBio kwakashanduka kuita kubatana kwenguva refu, nemakambani ese ari kubatsirwa kubva mukugovaniswa kukura uye hunyanzvi.
Nekubatanidza tekinoroji yemhando yepamusoro, masisitimu emhando yepamusoro, uye mhinduro dzakagadzirirwa, FCE inoenderera mberi nekuisa bhenji rekunyatso uye kuvimbika muindasitiri yekugadzira michina yekurapa.
Nguva yekutumira: Nov-28-2024