I-Huamei Laser Ithobela Uhlaziyo Lwemithetho Ukuqinisekisa Umgangatho Nenkxaso Yabasasazi Behlabathi

I-Huamei Laser, umenzi ophambili wezixhobo ze-laser, iqinisekisa kwakhona ukuzibophelela kwayo ekuqinisekiseni umgangatho kunye nokuthobela imigangatho yehlabathi ngokuhlaziya ngokukhawuleza i-Medical Device Directive (MDD) yayo kwi-Medical Device Regulation entsha (MDR). Eli nyathelo ligxininisa ukuzinikela kwenkampani ekuhlangabezaneni neemfuno zomthetho kunye nokuqinisekisa imigangatho ephezulu yokhuseleko kunye nokusebenza kakuhle kweemveliso zayo.

Utshintsho oluvela kwi-MDD ukuya kwi-MDR lubonisa utshintsho olukhulu kwiimfuno zomthetho zezixhobo zonyango ngaphakathi kwiManyano yaseYurophu. Ngokuhlaziya ukuya kwi-MDR, i-Huamei Laser iqinisekisa ukuba izixhobo zayo ze-laser ziyahlangabezana nemigangatho yamva nje kunye neenkcukacha ezifunekayo yimigaqo ye-EU. Le ndlela yokubonisa ukusebenza kakuhle ayibonisi nje kuphela ukuba inkampani iyakwazi ukuguquguquka kodwa ikwaphucula ukuzithemba phakathi kwabathengi kunye nabachaphazelekayo malunga nomgangatho kunye nokhuseleko lweemveliso zayo.

"Ukuqinisekisa ukuthotyelwa kohlaziyo lwemithetho kubaluleke kakhulu kuthi," utshilo uDavid, iBoss kwiHuamei Laser. "Ngokutshintshela kwi-MDR ngexesha elifanelekileyo, sigcina ukuzibophelela kwethu ekunikezeni izixhobo zelaser ezikhuselekileyo nezisebenzayo ezihlangabezana nemigangatho ephezulu yomgangatho kunye nokusebenza."

Ukongeza ekuhlaziyeni i-MDD yayo ibe yi-MDR, i-Huamei Laser ikwakwinkqubo yokufaka isicelo sesiqinisekiso se-Medical Device Single Audit Program (MDSAP). Isiqinisekiso se-MDSAP siyavunywa ziigunya ezininzi zomthetho, kuquka ezo zase-Australia, eBrazil, eKhanada, eJapan, nase-United States. Ngokufumana isatifikethi se-MDSAP, i-Huamei Laser ijolise ekuqiniseni ngakumbi imizamo yayo yokuthobela imithetho kunye nokuxhasa izilangazelelo zabasasazi bayo kwezi marike ziphambili.

"Ukufuna isiqinisekiso se-MDSAP kuhambelana nesicwangciso sethu sokubonelela abasasazi bethu behlabathi ngeziqinisekiso ezifunekayo zokungenisa nokusasaza iimveliso zethu," wongeze watsho uDavid. "Olu qinisekiso aluyi kulungisa nje kuphela inkqubo yolawulo kodwa luza kuphucula ubudlelwane bethu nabasasazi, luqinisekise impumelelo kunye nokukhula okuqhubekayo."

Indlela yeHuamei Laser yokuthobela imithetho igxininisa ukuzinikela kwayo okungagungqiyo kumgangatho nokhuseleko kuyo yonke imveliso yayo. Ngokuhlala inolwazi ngohlaziyo lwemithetho kunye nokufumana iziqinisekiso ezifanelekileyo, inkampani iqinisekisa isikhundla sayo njengomboneleli othembekileyo wezixhobo ze-laser kwihlabathi liphela.