Isiqinisekiso se-ISO13485 kunye neZakhono eziPhakamileyo: Igalelo leFCE kwiZixhobo zoNyango zeAesthetic

FCEuyazingca ngokuqinisekiswa phantsi kwe-ISO13485, umgangatho owaziwayo kwihlabathi jikelele weenkqubo zolawulo lomgangatho kwimveliso yezixhobo zonyango. Esi satifikethi sibonisa ukuzibophelela kwethu ekufezekiseni iimfuno ezingqongqo zeemveliso zonyango, siqinisekisa ukuthembeka, ukulandeleka, kunye nokugqwesa kuyo yonke inkqubo. Ngokudityaniswa negumbi lethu elicocekileyo leKlasi ye-100,000, sineziseko kunye nobuchule bokuvelisa iimveliso ezihlangabezana nemigangatho ephezulu yokhuseleko kunye nokusebenza, kubandakanywa nokuthotyelwa kweemfuno ze-FDA.

Ukusebenzisana kunye ne-Bioo: i-Aesthetic Device Innovation

NjengoBio, inkampani esebenza kwizixhobo zonyango zobuhle obubambekayo, ifune umboneleli onamandla obunjineli kunye nophuhliso olomeleleyo kunye nezixhobo zokucoceka eziqinisekisiweyo ze-ISO13485. Kwangoko kukhangelo lwabo, bachonge i-FCE njengelona qabane lifanelekileyo. Njenge-Bio ekuqaleni ibonelele ngemodeli ye-3D yesixhobo sabo, esifuna ukuphuculwa kokusebenza kunye nobuhle.

I-FCE yenze uphononongo olubanzi loyilo kunye nesiphakamiso solungelelaniso oluninzi ngokusekwe kumava ethu okwenziwa kwemveliso. Ukulinganisa ukusebenza kobugcisa kunye neemfuno zobuhle, siye sasebenzisana ngokusondeleyo nomxhasi ngokuphindaphinda kaninzi, ekugqibeleni sigqibezela isisombululo esigqithise ulindelo lwabo.

Imiceli mngeni kuMataniso oMbala ngokweSiko weIzicelo zonyango

Ngenxa yobuhle bendalo yemveliso, NjengoBio ucele okuluhlaza njengowona mbala uphambili. Ukufezekisa oku kufuna ukoyisa imingeni ebalulekileyo, kubandakanywa nokukhetha izixhobo ezifanelekileyo, ukuqinisekisa ukuxubana kombala ngokuchanekileyo, kunye nokugcina imveliso ephezulu yemveliso.

I-FCE icebise ngeentlaka zeplastiki zodidi lwezonyango ezidityaniswe nezongezo zombala ezikhuselekileyo ekutyeni ukuze kuphunyezwe iziphumo ezifunwayo. Emva kokuvelisa iisampulu zokuqala, umbala ulungelelaniswe kakuhle ngokuthelekisa izinto ezikhethwa ngumxhasi kunye neeswatshi zombala ezisemgangathweni. Le ndlela ingqongqo ibangele ukwakheka kombala oqhelekileyo odibana ngokugqibeleleyo nolindelo lomxumi.

Ukusebenzisa i-DHR ngokulandelelwa kunye noQinisekiso loMgangatho

Ukuthotyelwa kwe-ISO13485 kufuna uxwebhu olucokisekileyo kunye nokulandeleka kuyo yonke inkqubo yokuvelisa. Kwi-FCE, sithobela inkqubo yokulawula iNgxelo yeMbali yeDivaysi (i-DHR), ebhala yonke into yokuvelisa, kubandakanywa amanani ebhetshi, iiparitha, kunye neerekhodi zokulawula umgangatho. Oku kusenza sikwazi ukulandelela iirekhodi zemveliso ukuya kutsho kwiminyaka emihlanu, siqinisekisa ukuphendula okungenakulinganiswa kunye nenkxaso emva kokuveliswa.

Impumelelo yexesha elide ngeNtsebenziswano

Ukuzinikezela kweFCE kumgangatho, ukubambelela ngokungqongqo kwimigangatho ye-ISO13485, kunye nokukwazi ukusombulula imingeni entsonkothileyo yokwenziwa kwemveliso kusenze saduma. Intsebenziswano yethu kunye ne-Like Bio iye yavela kwintsebenziswano yexesha elide, kunye neenkampani zombini ezixhamla ekukhuleni okwabelwanayo kunye nokusungula izinto ezintsha.

Ngokudibanisa itekhnoloji ephucukileyo, iinkqubo ezingqongqo ezisemgangathweni, kunye nezisombululo ezilungiselelweyo, iFCE iyaqhubeka nokubeka ibhenchmark yokuchaneka nokuthembeka kushishino lokwenziwa kwezixhobo zonyango.