I-ISO13485 Isiqinisekiso kunye neZakhono eziPhambili: Igalelo likaFCE kwizixhobo zonyango

FceInebhongo yokuqinisekiswa phantsi kwe-ISO13485, uMgangatho owamkelweyo kwihlabathi jikelele weenkqubo zolawulo lomgangatho kwimveliso yesixhobo sezonyango. Esi siqinisekiso sibonisa ukuzibophelela kwethu ekufezekiseni iimfuno ezinqabileyo kwiimveliso zonyango, ukuqinisekisa ukuthembeka, ukulandelela nokugqwesa kuyo yonke inkqubo. Idityaniswe neklasi yethu ye-Artity ye-ART 100,000 igumbi lokucoca, sineziseko zophuhliso kunye nobuchule bokuvelisa iimveliso ezihlangabezana nemigangatho ephezulu yokhuseleko kunye nokusebenza, kubandakanya ukuthotyelwa kweemfuno ze-FDA.

Ukudibana kunye ne-Bio: Isixhobo se-Okuyisi

I-Bio, inkampani ijolise ekuphathweni kwezixhobo zonyango zezobugcisa, zifuna umthengisi onobuchule obuqinileyo bobunjineli kunye nezakhono zophuhliso kunye ne-ISO13485. Kwangoko ukukhangela kwabo, bachonga i-goce njengeqabane elifanelekileyo. Njenge-bio ekuqaleni babonelela ngemodeli ye-3D yesixhobo sabo, esifuna ukusebenza kunye nokuhlaziya okuthile.

I-FCE iqhube uphononongo olubanzi loyilo kunye nolondolozo olucetywayo olucetywayo olusekwe kumava okwenza imveliso. Ukulungelelanisa ukusebenza kwezehlo kunye neemfuno zobuhle, sisebenzisane nomthengi ngemibandela emininzi, ekugqibeleni kugqitywe isisombululo esigqitha kulindelo lwabo.

Imiceli mngeni kumbala wesiqheloIzicelo zonyango

Ngenxa yobume obuthile yemveliso, njenge-bio iluhlaza iceliwe njengombala ophambili. Ukufezekisa oku kufuna ukoyisa imiceli mngeni ebalulekileyo, kubandakanya ukukhetha izixhobo ezifanelekileyo, ukuqinisekisa ukuxutywa kombala okhethekileyo, kunye nokugcina izivuno eziphezulu zemveliso.

I-FCE iphakamise i-Gransies yeBanga leMidlalo yePhambili edityanisiweyo kunye nezongezo zombala wokutya ukufezekisa iziphumo ozifunayo. Emva kokuvelisa iisampulu zokuqala, umbala wawulungile ngokusebenzisa ukuthelekisa kunye nokhetho olukhethiweyo lwabathengi kunye nokukhetha imibala emigangathweni. Le ndlela ingqongqo yakhokelela ekubeni ifomuculakot yokombala yesiqhelo yahlangabezana kakuhle nolindelo lwabathengi.

Ukuqesha i-DHR yokuqeshisa kunye nokuqinisekiswa komgangatho

I-IS13485 Ukuthotyelwa kufuna amaxwebhu acetywayo kunye nokulandelela ukuphela kwenkqubo yokwenziwa. E-FCE, sibambelela kwinkqubo yolawulo lwembali yomeleleyo (i-DHR) yeNkqubo yokuLawulwa kweMveliso, kubandakanya yonke imiba yemveliso, kubandakanya neenombolo ze-batch, iiparamitha, kunye neerekhodi zolawulo lomgangatho. Oku kusenza ukuba sikwazi ukulandela iirekhodi zemveliso ukuya kwiminyaka emihlanu, ukuqinisekisa ukuphendula ngendlela engeyiyo kunye nenkxaso yemveliso yasemva kwemveliso.

Impumelelo yexesha elide ngokusebenzisana

I-FCE's Hissistic kumgangatho, ukunamathela ngokungqongqo kwimigangatho ye-IS13485, kunye nokukwazi ukusombulula iingxaki zokuvelisa izinto ezintsonkothileyo kufumene udumo lweStellar. Intsebenziswano yethu efana ne-BIO ivele kwintsebenziswano yexesha elide, kunye neenkampani zombini ezixhamla ekukhuleni okwabelwana ngako kunye nokuyilwa kwemveliso.

Ngokudibanisa itekhnoloji edibeneyo, iinkqubo ezingqongqo zomgangatho, kunye nezisombululo ezilungelelanisiweyo, i-FCE iyaqhubeka ukuseta uphawu lokuchaneka kunye nokuthembeka kwishishini lokwenza ishishini.