Izindaba ezinhle! Ngo-Okthoba 16, 2020, i-Shenzhen Pentasmart Technology CO,. Ltd iwine isitifiketi se-ISO13485 sohlelo lokuphatha idivayisi.

Igama eligcwele le-ISO13485: izinga lika-2016 liyizimfuneko zesistimu yokuphatha idivayisi yezokwelapha-Ikhwalithi yokulawula, eyakhiwa iKomidi Lobuchwepheshe le-SCA / TC221 mayelana nokuphathwa kwekhwalithi kanye nezidingo ezijwayelekile zokumiswa kwamadivayisi wezokwelapha, asetshenziswa kabanzi emhlabeni. I-ISO 9001, EN 46001 noma i-ISO 13485 ngokuvamile isetshenziswa njengezimfuneko zesistimu yokuqinisekisa ikhwalithi e-United States, Canada naseYurophu. Ukusungulwa kwesistimu yokuqinisekisa ikhwalithi yedivayisi yezokwelapha kusekelwe kulawa mazinga. Uma imishini yezokwelapha ifuna ukungena ezimakethe zamazwe ahlukene eNyakatho Melika, eYurophu noma e-Asia, kufanele ihambisane nemithethonqubo ehambisanayo.

Ngalesi sikhathi, iPentasmart yathola isitifiketi, esithuthukise kakhulu izinga lokuphatha lebhizinisi futhi yaqinisekisa izinga lekhwalithi yemikhiqizo, ngaleyo ndlela yandisa ukuthandwa kwebhizinisi, yandisa ukuncintisana kwemikhiqizo, isusa izithiyo zokuhweba kanye nokuthola imvume yokungena. imakethe yamazwe ngamazwe.