Isitifiketi se-ISO13485 kanye Namakhono Athuthukile: Igalelo le-FCE Kumadivayisi Ezokwelapha Obuhle

FCEiyaziqhenya ngokunikezwa isitifiketi ngaphansi kwe-ISO13485, izinga elaziwa emhlabeni wonke lezinhlelo zokuphatha ikhwalithi ekukhiqizweni kwemishini yezokwelapha. Lesi sitifiketi sibonisa ukuzibophezela kwethu ekuhlangabezaneni nezidingo eziqinile zemikhiqizo yezokwelapha, siqinisekisa ukwethembeka, ukulandeleka, kanye nokwenza kahle kuyo yonke inqubo. Ngokuhambisana negumbi lethu lokuhlanza le-Class 100,000 lesimanjemanje, sinengqalasizinda nobungcweti bokukhiqiza imikhiqizo ehlangabezana namazinga aphezulu okuphepha nokusebenza, okuhlanganisa nokuhambisana nezidingo ze-FDA.

Ukusebenzisana ne-Like Bio: I-Aesthetic Device Innovation

Njengo-Bio, inkampani esebenza ngemishini yezokwelapha ephathwayo yobuhle, ifune umphakeli onekhono eliqinile lobunjiniyela nentuthuko kanye nezindawo zokuhlanza ezinezitifiketi ze-ISO13485. Ekuqaleni kokusesha kwabo, bahlonze i-FCE njengozakwethu ofanelekile. Njengo-Bio ekuqaleni unikeze imodeli ye-3D yedivayisi yabo, eyayidinga kokubili ukuthuthukiswa kokusebenza nobuhle.

I-FCE yenze isibuyekezo esibanzi somklamo futhi yaphakamisa ukulungiselelwa okuningi ngokusekelwe kumuzwa wethu obanzi wokukhiqiza. Ukulinganisa ukusebenza kwezobuchwepheshe kanye nezidingo zobuhle, sibambisene eduze neklayenti ngokuphindaphinda okuningana, ekugcineni siphothula isixazululo esidlule ababekulindele.

Izinselelo Ekufaniseni Umbala Ngokwezifiso zeIzicelo Zezokwelapha

Ngokunikezwa kwemvelo yobuhle bomkhiqizo, Njengo-Bio ocele okuluhlaza njengombala oyinhloko. Ukufeza lokhu kwakudinga ukunqoba izinselele ezibalulekile, okuhlanganisa ukukhetha izinto ezifanele, ukuqinisekisa ukuxutshwa kombala okunembayo, nokugcina isivuno esiphezulu sokukhiqiza.

I-FCE yancoma ama-resin epulasitiki ebanga lezokwelapha ahlanganiswe nezithasiselo zombala eziphephile ekudleni ukuze kuzuzwe umphumela oyifunayo. Ngemva kokukhiqiza amasampula okuqala, umbala walungiswa kahle ngokuqhathaniswa nokuthandwayo kweklayenti okuzimele kanye nama-swatches ombala amisiwe. Le ndlela eqinile ibangele ukwakheka kombala ngokwezifiso okuhlangabezana kahle nokulindelwe yiklayenti.

Ukusebenzisa i-DHR Ukulandeleka Nokuqinisekisa Ikhwalithi

Ukuthobela i-ISO13485 kudinga imibhalo ecophelelayo kanye nokulandeleka kuyo yonke inqubo yokukhiqiza. Kwa-FCE, sibambelela ohlelweni oluqinile lokuphatha Irekhodi Lomlando Wedivayisi (i-DHR), ebhala zonke izici zokukhiqiza, okuhlanganisa izinombolo zeqoqo, amapharamitha, namarekhodi okulawula ikhwalithi. Lokhu kusenza sikwazi ukulandelela amarekhodi okukhiqiza kuze kufike eminyakeni emihlanu, siqinisekise ukuziphendulela okungenakuqhathaniswa kanye nokwesekwa kwangemuva kokukhiqiza.

Impumelelo Yesikhathi Eside Ngokusebenzisana

Ukuzinikela kwe-FCE kukhwalithi, ukubambelela ngokuqinile ezimisweni ze-ISO13485, kanye nekhono lokuxazulula izinselele eziyinkimbinkimbi zokukhiqiza kusenze saduma kakhulu. Ubambiswano lwethu ne-Like Bio seluguquke lwaba ukusebenzisana kwesikhathi eside, zombili izinkampani zihlomula ekukhuleni okwabiwe kanye nokusungula izinto ezintsha.

Ngokuhlanganisa ubuchwepheshe obuthuthukisiwe, amasistimu ekhwalithi aqinile, nezisombululo ezihambisanayo, i-FCE iyaqhubeka nokubeka ibhentshimakhi yokunemba nokuthembeka embonini yokukhiqiza idivayisi yezokwelapha.