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

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

Ushintsho lusuka ku-MDD luye ku-MDR lubonisa ushintsho olukhulu ezidingweni zokulawula zamadivayisi ezokwelapha ngaphakathi kwe-European Union. Ngokuthuthukela ku-MDR, i-Huamei Laser iqinisekisa ukuthi imishini yayo ye-laser ihlangabezana nezindinganiso zakamuva kanye nokucaciswa okugunyazwe yimithetho ye-EU. Le ndlela yokwenza izinto ngokushesha ayibonisi nje kuphela ukuzivumelanisa nezimo kwenkampani kodwa futhi ithuthukisa ukuzethemba phakathi kwamakhasimende nababambiqhaza mayelana nekhwalithi nokuphepha kwemikhiqizo yayo.

"Ukuqinisekisa ukuthi siyahambisana nezibuyekezo zemithetho kubalulekile kithi," kusho uDavid, iBoss eHuamei Laser. "Ngokushintshela ku-MDR ngesikhathi esifanele, sisekela ukuzibophezela kwethu ekuletheni imishini ye-laser ephephile nephumelelayo ehlangabezana namazinga aphezulu kakhulu ekhwalithi nokusebenza."

Ngaphezu kokubuyekeza i-MDD yayo ku-MDR, i-Huamei Laser nayo isemkhankasweni wokufaka isicelo sokuthola isitifiketi se-Medical Device Single Audit Programme (MDSAP). Isitifiketi se-MDSAP sibonwa iziphathimandla eziningi zokulawula, okuhlanganisa nalezo ezise-Australia, Brazil, Canada, Japan, nase-United States. Ngokuthola isitifiketi se-MDSAP, i-Huamei Laser ihlose ukuqhubeka nokuqinisa imizamo yayo yokuthobela imithetho futhi isekele izintshisekelo zabasabalalisi bayo kulezi zimakethe ezibalulekile.

"Ukuphishekela ukuthola isitifiketi se-MDSAP kuhambisana nesu lethu lokuhlinzeka abasabalalisi bethu bomhlaba wonke ngeziqu ezidingekayo zokungenisa nokusabalalisa imikhiqizo yethu," kwengeza uDavid. "Lesi sitifiketi ngeke sihlehlise inqubo yokulawula kuphela kodwa futhi sithuthukise ubudlelwano bethu nabasabalalisi, siqinisekise impumelelo efanayo kanye nokukhula okuqhubekayo."

Indlela ye-Huamei Laser esebenzayo yokuthobela imithetho igqamisa ukuzibophezela kwayo okungantengantengi kukhwalithi nokuphepha kulo lonke uhla lomkhiqizo wayo. Ngokuhlala inolwazi ngezibuyekezo zokulawula kanye nokuthola izitifiketi ezifanele, inkampani iqinisekisa isikhundla sayo njengomhlinzeki othembekile wemishini ye-laser emhlabeni wonke.