Kutshanje, i-haiyan kangoan yezonyangoIsixhobo CO.Uphengululo luthatha iintsuku ezintathu,rejongene nenkqubo yolawulo lomgangatho, ukuchongwa kwenkqubo kunye nohlalutyo, uxanduva lolawulo, iinjongo ezisemgangathweni, uHlaziyo, ukuSebenza, ukuSebenza, ukuBonelela kwiWerehouse, uLawulo loMngcipheko, inkqubo Ukuqinisekiswa, ukuqinisekiswa kweSterilizolic, ukulandelela, ukhuseleko lwemveliso, ukubeka iliso kunye nokulawulwa kwezixhobo zolawulo lwezixhobo, kubandakanya amanyathelo okhuselo, uPhicotho-zincwadi, uPhando loLuntu, njl.

This UPhicotho-zincwadi, ungqinisiswe liqela lophicotho-zincwadi kwisayithi, uqinisekisile ukuba zonke iinkqubo zophando lwe-kangoan zezonyango, imveliso kunye nentengiso zenziwa ngokungqinelana nezibonelelo zolawulo lomgangatho, kwaye kuyacetyiswa ukukhupha isatifikethi.

Njengomgangatho wenkqubo yolawulo esemgangathweni wamazwe ngakwimigangatho yesixhobo sonyango, iSo elandelayo yeSO13485: 2016 (Inkqubo yoLawulo lweSixhobo soNyango lweeMpilo zeMgaqo-nkqubo) ikhutshwe ngokusemthethweni nge-1 kaMatshi 2016.Inguqulelo ye-ISO13485 emiselweyo ye-ISO13485 yongeza inani elikhulu lezixhobo zezonyango, ziyahambelana neemfuno zeMigaqo yeSixhobo seSizwe soNyango yeZonyango, yinkqubo yolawulo esemgangathweni kunye nokubekwa esweni imigangatho elawulwa ngokusondeleyo.

I-Kangoan Igqirha edluliselwe kwisatifikethi sesithathu, esingabonisi kuphela ukwamkelwa ngokubanzi kweemveliso ze-kangoan ngemibutho yeMigangatho yeHlabathi, iMigangatho kunye nokuSebenza kumaLiaan Umgangatho woLawulo lweMigangatho yoNyango.

Okwangoku, i-kangoan yezonyango ikwasebenza ne-US FDA, i-EU MDR isicelo kunye nomnye umsebenzi.Sinethemba lokuba ngenkxaso yehlabathi jikelele "yedlule", i-kangoan iya kugubungela zonke iintlobo ze-cathetheters ze-silicone, i-casheters ye-cacetheters, endoI-Tracheal Tube, iFusiikhethe, i-tube yesisu, imaski eyahlukeneyo kunye nezinye izinto ezinokusebenzisa iimveliso zehlabathi, kwaye zinceda abantu abaguli emhlabeni, kwaye zinceda iimveliso zonyango ziphuculwe ngokupheleleyo!