Huamei Laser, e leng moetsi ea ka sehloohong oa thepa ea laser, e tiisa boitlamo ba eona ba netefatso ea boleng le ho latela litekanyetso tsa lefats'e ka ho nchafatsa Medical Device Directive ea eona (MDD) ho Molao o mocha oa Medical Device Regulation (MDR). Ts'ebetso ena e totobatsa boitlamo ba k'hamphani ho fihlela litlhoko tsa taolo le ho netefatsa maemo a holimo a polokeho le katleho bakeng sa lihlahisoa tsa eona.
Phetoho ho tloha ho MDD ho ea ho MDR e bolela phetoho e kholo litlhoko tsa taolo bakeng sa lisebelisoa tsa bongaka ka hare ho European Union. Ka ho nchafatsa MDR, Huamei Laser e netefatsa hore thepa ea eona ea laser e kopana le litekanyetso tsa morao-rao le litlhaloso tse laetsoeng ke melao ea EU. Mokhoa ona oa ho sebetsa ka mafolo-folo ha o bontše feela ho ikamahanya le maemo ha k'hamphani empa o boetse o matlafatsa kholiseho har'a bareki le ba amehang mabapi le boleng le polokeho ea lihlahisoa tsa eona.
"Ho netefatsa hore re latela lintlafatso tsa taolo ho bohlokoa ho rona," ho boletse David, Boss ho Huamei Laser. "Ka ho fetela ho MDR ka nako e nepahetseng, re tšehetsa boitlamo ba rona ba ho fana ka lisebelisoa tsa laser tse sireletsehileng le tse sebetsang tse finyellang litekanyetso tse phahameng ka ho fetisisa tsa boleng le ts'ebetso."
Ntle le ho nchafatsa MDD ea eona ho MDR, Huamei Laser e boetse e mothating oa ho etsa kopo ea setifikeiti sa Medical Device Single Audit Program (MDSAP). Setifikeiti sa MDSAP se amoheloa ke balaoli ba bangata, ho kenyeletsoa ba Australia, Brazil, Canada, Japan le United States. Ka ho fumana setifikeiti sa MDSAP, Huamei Laser e ikemiselitse ho matlafatsa boiteko ba eona ba ho latela melao le ho ts'ehetsa lithahasello tsa barekisi ba eona mebarakeng ena ea bohlokoa.
"Ho lelekisa setifikeiti sa MDSAP ho tsamaellana le leano la rona la ho fa barekisi ba rona ba lefats'e ka litšoaneleho tse hlokahalang ho kenya le ho aba lihlahisoa tsa rona," David a eketsa. "Setifikeiti sena se ke ke sa fokotsa ts'ebetso ea taolo feela empa hape se tla ntlafatsa likamano tsa rona le baabi, ho netefatsa katleho e tšoanang le kholo e tsoelang pele."
Mokhoa o sebetsang oa Huamei Laser oa ho latela melao o totobatsa boitlamo ba eona bo sa thekeseleng ba boleng le polokeho ho pholletsa le lihlahisoa tsa eona. Ka ho lula e tseba ka lintlafatso tsa taolo le ho fumana litifikeiti tse amehang, khamphani e tiisa boemo ba eona e le mofani ea tšepahalang oa thepa ea laser lefatšeng ka bophara.
Nako ea poso: Apr-23-2024