ISO13485 Icyemezo nubushobozi buhanitse: Umusanzu wa FCE kubikoresho byubuvuzi bwiza

FCEyishimiye kwemezwa na ISO13485, igipimo cyemewe kwisi yose kuri sisitemu yo gucunga neza mubikorwa byubuvuzi. Iki cyemezo kigaragaza ubwitange bwacu bwo kuzuza ibisabwa bikenewe mubicuruzwa byubuvuzi, kwemeza kwizerwa, gukurikiranwa, no kuba indashyikirwa muri buri gikorwa. Twifatanije nu kijyambere kigezweho cy’icyumba cy’isuku 100.000, dufite ibikorwa remezo nubuhanga bwo gukora ibicuruzwa byujuje ubuziranenge bw’umutekano n’imikorere, harimo no kubahiriza ibisabwa na FDA.

Gufatanya na Nka Bio: Guhanga ibikoresho byiza

Kimwe na Bio, isosiyete izobereye mu bikoresho by’ubuvuzi by’uburanga, yashakishije isoko rifite ubushobozi bukomeye bw’ubuhanga n’iterambere ndetse n’ibikoresho by’isuku byemewe na ISO13485. Kera mubushakashatsi bwabo, bagaragaje FCE nkumufatanyabikorwa mwiza. Kimwe na Bio yabanje gutanga moderi ya 3D yibikoresho byabo, bisaba kunonosora imikorere ndetse nubwiza.

FCE yakoze isuzuma ryimbitse ku gishushanyo mbonera kandi itanga ibyifuzo byinshi bishingiye ku bunararibonye dufite bwo gukora. Kuringaniza imikorere ya tekiniki nibisabwa byuburanga, twakoranye cyane nabakiriya binyuze mubisubiramo byinshi, amaherezo turangiza igisubizo kirenze ibyo bari biteze.

Inzitizi mu Guhuza Ibara rya Customer forGusaba Ubuvuzi

Urebye imiterere yuburanga bwibicuruzwa, Nka Bio yasabye icyatsi nkibara ryibanze. Kugera kuri ibi bisabwa gutsinda imbogamizi zikomeye, harimo guhitamo ibikoresho bikwiye, kwemeza neza kuvanga amabara, no gukomeza umusaruro mwinshi.

FCE yasabye ubuvuzi bwa plastike yo mu rwego rwo kwa muganga ihujwe n’ibiribwa byangiza amabara kugira ngo bigere ku gisubizo cyifuzwa. Nyuma yo gutanga ibyitegererezo byambere, ibara ryatunganijwe neza mugereranya nibyifuzo byabakiriya hamwe nibisanzwe byamabara. Ubu buryo bukomeye bwatumye habaho ibara ryibara ryujuje ibyifuzo byabakiriya.

Gukoresha DHR kugirango ukurikirane kandi wizere neza

ISO13485 kubahiriza bisaba inyandiko zuzuye kandi zikurikiranwa mubikorwa byose. Muri FCE, twubahiriza sisitemu ikomeye yubuyobozi bwamateka yububiko (DHR), yerekana ibintu byose byakozwe, harimo nimero yicyiciro, ibipimo, hamwe nubugenzuzi bwubuziranenge. Ibi bidushoboza gukurikirana inyandiko zibyara umusaruro mugihe cyimyaka itanu, tukemeza kubazwa ntagereranywa hamwe ninkunga yatanzwe nyuma yumusaruro.

Intsinzi Yigihe kirekire Binyuze Mubufatanye

Ubwitange bwa FCE ku bwiza, gukurikiza byimazeyo ibipimo bya ISO13485, hamwe n'ubushobozi bwo gukemura ibibazo bikomeye byo gukora byaduteye izina ryiza. Ubufatanye bwacu na Like Bio bwahindutse mubufatanye burambye, hamwe namasosiyete yombi yunguka iterambere risangiwe no guhanga udushya.

Muguhuza ikoranabuhanga rigezweho, sisitemu yubuziranenge ikomeye, hamwe nigisubizo cyihariye, FCE ikomeje gushyiraho ibipimo ngenderwaho byukuri kandi byizewe mubikorwa byubuvuzi.