Iso13485 Icyemezo nubushobozi bwambere: Uruhare rwa FCE mubikoresho byubuvuzi bya Astethetic

FCEYishimiye kwemezwa munsi ya Iso13485, amahame yamenyekanye kwisi yose muri sisitemu yubuyobozi bwiza mubikoresho byubuvuzi. Iri tegeko ryerekana ibyo twiyemeje kugira ngo duhuze ibisabwa n'ibisabwa mu bicuruzwa, tubitere imbere kwizerwa, gukurikirana, no kuba indashyikirwa muri buri nzira. Hamwe na leta-yubuhanzi-ubuhanzi-ubuhanzi bwicyumba 100.000, dufite ibikorwa remezo nubuhanga bwo gutanga ibicuruzwa byujuje ubuziranenge bwumutekano n'imikorere, harimo kubahiriza ibisabwa na FDA.

Gufatanya na Bio: Igikoresho cyongero

Kimwe na bio, isosiyete ihindagurika mu bikoresho byo kwivuza byashushanyije, yashakishije umutanga ufite ubuhanga bwo mu buhanga n'iterambere ndetse n'ubushobozi bwo kwiteza hamwe na Iso13485. Kera mu gushakisha, bagaragaje FECE nkumufatanyabikorwa mwiza. Kimwe Bio kubanza gutanga icyitegererezo cya 3D cyigikoresho cyabo, gisaba kunonosora byombi imikorere kandi nziza.

FCE yakoze isubiramo ryuzuye ryigishushanyo kandi gisaba guhitamo byinshi gishingiye kubikorwa byacu byo gukora. Balancing technical functionality and aesthetic requirements, we collaborated closely with the client through several iterations, eventually finalizing a solution that exceeded their expectations.

INGORANE MU BISOKO BYINSHI BIKURIKIRAGusaba Ubuvuzi

Urebye imiterere yibicuruzwa, nka bio yasabwe icyatsi nkibara ryibanze. Kugera kuri ibi bisabwa kunesha ibibazo bikomeye, harimo guhitamo ibikoresho bikwiye, kureba neza kuvanga ibara, no gukomeza umusaruro mwinshi.

FCE yasabye ko ishyari rya plastike yubuvuzi zahujwe nibiryo-bifite amabara meza kugirango ugere kubisubizo wifuza. Nyuma yo gukora ingero zambere, ibara ryari rifite agaciro ryiza binyuze mu kugereranya hamwe nibisabwa nabakiriya hamwe nibara ryibara risanzwe. Uku buryo bukomeye bwatumye amabara yihariye yahuye neza nabakiriya bariteze.

Gutanga DHR kubishushanyo mbonera nicyizere cyiza

Iso13485 kubahiriza ibyifuzo nibisobanuro byose muburyo bukora. Muburyo bwa FCE, dukurikiza uburyo bwamateka yibikorwa byanditseho (DHR), inyandiko yerekana ibintu byose byumusaruro, harimo nimero yicyiciro, hamwe ninyandiko zigenzura. Ibi bidushoboza gukurikirana imisaruro kugeza ku myaka itanu, kwemeza ko abashinzwe umutekano bagereranywa no gushyigikirwa nyuma.

Intsinzi ndende binyuze mubufatanye

Ubwitange bwa FCE kuri Bweri, gukurikiza cyane Iso13485, nubushobozi bwo gukemura ibibazo byinganda bigoye byaduhaye izina rya Stellar. Ubufatanye bwacu na Bio bwahindutse ubufatanye burebure, hamwe nibisosiyete yombi bungukirwa no gukura kwabisangiwe no guhanga udushya.

Muguhuza ikoranabuhanga ryiza, sisitemu nziza nziza, hamwe nibisubizo bihujwe, FCE ikomeje gushyiraho igipimo cyo gushushanya no kwiringirwa muburyo bwo gukora ibikoresho byubuvuzi.