I-Laser ye-Huamei ihambelana noHlaziyo oluLawulayo ukuze kuqinisekiswe uMgangatho kunye neNkxaso ye-Global Distributors

I-Huamei Laser, umenzi okhokelayo wezixhobo ze-laser, iqinisekisa ukuzibophelela kwayo ekuqinisekiseni umgangatho kunye nokuthotyelwa kwemigangatho yehlabathi ngokuhlaziya ngokukhawuleza i-Medical Device Directive (MDD) kwi-Medical Device Regulation (MDR). Eli nyathelo ligxininisa ukuzinikela kwenkampani ekufezekiseni iimfuno zolawulo kunye nokuqinisekisa imigangatho ephezulu yokhuseleko kunye nokusebenza ngempumelelo kweemveliso zayo.

Utshintsho ukusuka kwi-MDD ukuya kwi-MDR lubonisa utshintsho olubalulekileyo kwiimfuno zolawulo lwezixhobo zonyango ngaphakathi kwi-European Union. Ngokuhlaziywa kwi-MDR, i-Huamei Laser iqinisekisa ukuba izixhobo zayo ze-laser zihlangabezana nemigangatho yamva nje kunye neenkcukacha ezigunyazisiweyo yimimiselo ye-EU. Le ndlela yokuthatha inyathelo ayibonisi nje ukuguquguquka kwenkampani kodwa yongeza ukuzithemba phakathi kwabathengi kunye nabachaphazelekayo malunga nomgangatho kunye nokhuseleko lweemveliso zayo.

"Ukuqinisekisa ukuthotyelwa kohlaziyo lolawulo kubaluleke kakhulu kuthi," utshilo uDavid, uBoss eHuamei Laser. "Ngokutshintshela kwi-MDR ngexesha elifanelekileyo, sixhasa ukuzinikela kwethu ekunikezeni izixhobo ze-laser ezikhuselekileyo nezisebenzayo ezihlangabezana nemigangatho ephezulu yomgangatho kunye nokusebenza."

Ukongeza ekuhlaziyeni i-MDD yayo kwi-MDR, i-Huamei Laser nayo ikwinkqubo yokufaka isicelo se-Medical Device Single Audit Programme (MDSAP). Isatifikethi se-MDSAP samkelwa ngabasemagunyeni abaninzi abalawulayo, kuquka abo base-Australia, eBrazil, eKhanada, eJapan, nase-United States. Ngokufumana isatifikethi se-MDSAP, i-Huamei Laser ijonge ukomeleza ngakumbi iinzame zayo zokuthobela kunye nokuxhasa umdla wabasasazi bayo kwezi marike ziphambili.

"Ukulandela isiqinisekiso se-MDSAP sihambelana nesicwangciso sethu sokubonelela abasasazi bethu behlabathi ngeziqinisekiso eziyimfuneko zokungenisa kunye nokuhambisa iimveliso zethu," wongeze watsho uDavid. "Esi siqinisekiso asiyi kulungelelanisa inkqubo yokulawula kuphela kodwa siphucula ubudlelwane bethu nabasasazi, ukuqinisekisa impumelelo kunye nokukhula okuqhubekayo."

I-Huamei Laser's proactive approach ekuthotyelweni kwemithetho iqaqambisa ukuzibophelela kwayo okungagungqiyo kumgangatho nokhuseleko kulo lonke uluhlu lwemveliso. Ngokuhlala unolwazi ngohlaziyo lolawulo kunye nokufumana iziqinisekiso ezifanelekileyo, inkampani iphinda iqinisekise isikhundla sayo njengomboneleli othembekileyo wezixhobo zelaser kwihlabathi liphela.