Isitifiketi se-ISO13485 kanye namakhono athuthukile: umnikelo we-FCE kumadivayisi wezokwelapha anobuhle

Uhlobo lwemvuseleloUyaziqhenya ngokuqinisekiswa ngaphansi kwe-ISO13485, indinganiso eyaziwa emhlabeni jikelele yezinhlelo zokulawulwa kwekhwalithi ekukhiqizweni kwedivayisi yezokwelapha. Lesi sitifiketi sibonisa ukuzibophezela kwethu ekuhlangabezaneni nezidingo eziqinile zemikhiqizo yezokwelapha, ukuqinisekisa ukuthembeka, ukulandelela, kanye nokusebenza kahle kuzo zonke izinqubo. Kuhlanganiswe ne-State-of-the Art Cleanroom yethu ehlanzekile engu-100,000, sinengqalasizinda kanye nobuchwepheshe bokukhiqiza imikhiqizo ehlangabezana namazinga aphezulu okuphepha nokusebenza, kufaka phakathi ukuhambisana nezidingo ze-FDA.

Ukubambisana ne-bio: ubuhlakani bedivayisi

Njenge-bio, inkampani enakekela amadivaysi ezokwelapha eziphathwayo eziphathwayo, yafuna umphakeli onobunjiniyela obunamandla nobunjiniyela kanye ne-ISO13485-Cleanroom Cleanroom Cleanroom. Ekuqaleni kokusesha kwabo, bakhombe i-FCE njengomlingani ofanele. NjengoBio ekuqaleni unikeze imodeli ye-3D yedivayisi yabo, edinga ukucubungula okusebenzayo kanye nobuhle.

UFCE uqhube ukubuyekezwa okuphelele kokwakheka kwawo futhi kuhlongozwe ukuthi kungukusebenzela okuningi okususelwa kulwazi lwethu olubanzi lokukhiqiza. Ukulinganisa ukusebenza kwezobuchwepheshe kanye nezidingo zobuhle, sasebenzisana ngokubambisana neklayenti ngokusebenzisa amaklayenti amaningi, ekugcineni saphothula isisombululo esidlule okulindelwe.

Izinselelo Ekufanisweni kombala ngokwezifisoIzicelo zezokwelapha

Njengoba kunikezwe isimo sobuhle bomkhiqizo, njenge-bio eceliwe eluhlaza njengombala oyinhloko. Ukuthola lokhu kudinga ukunqoba izinselelo ezibalulekile, kufaka phakathi ukukhetha izinto ezifanele, uqinisekise ukuxuba umbala okuqondile, nokugcina ukukhiqiza okungcono kakhulu.

I-FCE yancomela ama-resins epulasitiki wezokwelapha ahlanganiswe nezithasiselo zemibala ephephile yokudla ukuze afeze umphumela oyifunayo. Ngemuva kokukhiqiza amasampula okuqala, umbala wawuhlelwe kahle ngokuqhathanisa nokuthandwa okushiwo yiklayenti kanye nokushintsha kombala okumisiwe. Le ndlela enzima yaholela ekwakhekeni kombala wangokwezifiso kuhlangane kahle okulindelwe kweklayenti.

I-DHR evuthayo yokuqothuka nokuqinisekiswa kwekhwalithi

Ukuhambisana kwe-ISO13485 kudinga amadokhumenti acophelela kanye nokulandela inqubo yonke yenqubo yokukhiqiza. E-FCE, sinamathela kuhlelo lokuphathwa komlando oluqinile (DHR) oluqinile, sibhala zonke izici zokukhiqiza, kufaka phakathi izinombolo ze-batch, amapharamitha namarekhodi okulawula amakhwalithi. Lokhu kusenza sikwazi ukulandelela amarekhodi okukhiqiza isikhathi esifinyelela eminyakeni emihlanu, siqinisekise ukuziphendulela okungenakuqhathaniswa nokusekelwa kwangemva kokukhiqizwa.

Impumelelo yesikhathi eside ngokusebenzisana

Ukuzinikela kwe-FCE kukhwalithi, ukubambelela okuqinile kumazinga we-ISO13485, kanye nekhono lokuxazulula izinselelo zokukhiqiza eziyinkimbinkimbi zithole idumela le-stellar. Ukubambisana kwethu nge-bio efana ne-bio kuguqulwe kwaba ukusebenzisana isikhathi eside, nazo zombili izinkampani zizuza ekukhuleni okwabiwe kanye nokwenziwa okusha.

Ngokuhlanganisa ubuchwepheshe obuthuthukisiwe, izinhlelo zekhwalithi eziqinile, kanye nezixazululo ezihambisana nezentengiso, i-FCE iyaqhubeka nokusetha ibhentshi ngokunemba nokwethenjwa embonini yokukhiqiza amadivaysi ezokwelapha.