Iindaba ezimnandi! Ngomhla we-16 ku-Okthobha, ngo-2020, i-Shenzhen Pentasmart Technology CO,. Ltd iphumelele isiqinisekiso senkqubo yolawulo lwesixhobo sonyango se-ISO13485.

Igama elipheleleyo le-ISO13485: umgangatho we-2016 yi-Medical device-Quality management system-requirements for regulatory, eyaqulunqwa yi-SCA / TC221 yeKomiti yezoBuchwephesha malunga nolawulo lomgangatho kunye neemfuno eziqhelekileyo zokulinganisa izixhobo zonyango, ezisetyenziswa ngokubanzi kwihlabathi. I-ISO 9001, i-EN 46001 okanye i-ISO 13485 isetyenziswa ngokubanzi njengeemfuno zenkqubo yokuqinisekisa umgangatho e-United States, eKhanada naseYurophu. Ukusekwa kwenkqubo yoqinisekiso lwezixhobo zonyango kusekwe kule migangatho. Ukuba izixhobo zonyango zifuna ukungena kwiimarike zamazwe ahlukeneyo eMntla Melika, eYurophu okanye e-Asia, kufuneka zihambelane nemimiselo ehambelanayo.

Ngeli xesha, iPentasmart yafumana isatifikethi, esiphucule kakhulu inqanaba lolawulo lweshishini kwaye yaqinisekisa umgangatho weemveliso, ngaloo ndlela yandisa ukuthandwa kweshishini, iphucula ukukhuphisana kweemveliso, isusa imiqobo yorhwebo kunye nokufumana ipasi lokungena. imarike yamazwe ngamazwe.