I-Huamei Laser Ihambisana Nezibuyekezo Zokulawula Ukuqinisekisa Ikhwalithi Nokusekela Abasabalalisi Bomhlaba Wonke

I-Huamei Laser, umkhiqizi ohamba phambili wemishini ye-laser, iqinisekisa ukuzibophezela kwayo ekuqinisekisweni kwekhwalithi kanye nokuhambisana nezindinganiso zomhlaba wonke ngokuvuselela ngokushesha i-Medical Device Directive (MDD) yayo ku-Medical Device Regulation (MDR) entsha. Lesi sinyathelo sigcizelela ukuzinikela kwenkampani ekuhlangabezaneni nezidingo zomthetho kanye nokuqinisekisa amazinga aphezulu okuphepha nokusebenza kahle kwemikhiqizo yayo.

Ukushintsha kusuka ku-MDD kuya ku-MDR kusho ushintsho olukhulu ezidingweni zomthetho zamadivayisi ezokwelapha ngaphakathi kwe-European Union. Ngokubuyekeza ku-MDR, i-Huamei Laser iqinisekisa ukuthi imishini yayo ye-laser ihlangabezana nezindinganiso zakamuva kanye nezincazelo ezifunwa yimithetho ye-EU. Le ndlela yokuqapha ayibonisi nje kuphela ukuthi inkampani iyakwazi ukuzivumelanisa nezimo kodwa futhi ithuthukisa ukuzethemba phakathi kwamakhasimende kanye nababambiqhaza mayelana nekhwalithi nokuphepha kwemikhiqizo yayo.

"Ukuqinisekisa ukuhambisana nezibuyekezo zomthetho kubaluleke kakhulu kithi," kusho uDavid, iBoss eHuamei Laser. "Ngokushintshela ku-MDR ngesikhathi esifanele, sigcina ukuzibophezela kwethu ekuletheni imishini ye-laser ephephile nephumelelayo ehlangabezana nezindinganiso eziphakeme kakhulu zekhwalithi nokusebenza."

Ngaphezu kokuvuselela i-MDD yayo ibe yi-MDR, i-Huamei Laser nayo isenqubweni yokufaka isicelo sesitifiketi se-Medical Device Single Audit Program (MDSAP). Isitifiketi se-MDSAP siqashelwa yiziphathimandla eziningi zomthetho, okuhlanganisa nalezo ezise-Australia, eBrazil, eCanada, eJapan nase-United States. Ngokuthola isitifiketi se-MDSAP, i-Huamei Laser ihlose ukuqinisa imizamo yayo yokuthobela imithetho nokusekela izintshisekelo zabasabalalisi bayo kulezi zimakethe ezibalulekile.

"Ukuphishekela isitifiketi se-MDSAP kuhambisana nesu lethu lokuhlinzeka abasabalalisi bethu bomhlaba wonke ngezimfanelo ezidingekayo zokungenisa nokusabalalisa imikhiqizo yethu," kusho uDavid. "Lesi sitifiketi ngeke sigcine nje ngokwenza lula inqubo yokulawula kodwa futhi sizothuthukisa ubudlelwano bethu nabasabalalisi, siqinisekise impumelelo nokukhula okuqhubekayo."

Indlela ye-Huamei Laser yokulandela imithetho igcizelela ukuzibophezela kwayo okungaguquki kwikhwalithi nokuphepha kuyo yonke imikhiqizo yayo. Ngokuhlala unolwazi ngezibuyekezo zomthetho nokuthola izitifiketi ezifanele, inkampani iqinisekisa isikhundla sayo njengomhlinzeki othembekile wemishini ye-laser emhlabeni jikelele.