"Iminyaka engaphezu kwengu-20 yoMkhiqizi Wezintambo Zezokwelapha Ochwepheshe eShayina"

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IZINDABA

Ekugcineni, i-Med-linket's Temperature Probe iwine isitifiketi se-Canadian CMDCAS

YABELANA:

Ngomhlaka-25 Meyi 2017, i-probe yokushisa esetshenziswa kwezokwelapha yacwaningwa futhi yathuthukiswa ngokuzimela yi-Shenzhen Med-linket Medical Electronics Co., Ltd. yathola isitifiketi se-Canadian CMDCAS

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Ingxenye yesithombe-skrini sesitifiketi sethu se-CMDCAS

 

Kubikwa ukuthi isitifiketi sedivayisi yezokwelapha yaseCanada sihlukile kwisitifiketi sase-US (FDA) esisingathwa ngokuphelele nguhulumeni ekubhalisweni komkhiqizo kanye nokubuyekezwa kukahulumeni endaweni (ukubuyekezwa kwe-GMP), sihlukile futhi kwisitifiketi saseYurophu (CE) esiqinisekiswe ngokuphelele yiqembu lesithathu, i-CMDCAS isebenzisa uhlelo lwekhwalithi oluqinisekiswe ukubhaliswa kukahulumeni kanye nokubuyekezwa kweqembu lesithathu. Umuntu wesithathu kumele futhi aqinisekiswe yiCanadian Medical Device.

 

Wonke amadivayisi ezokwelapha athengiswa emakethe yaseCanada kudingeka athole imvume evela ku-Canadian Medical Equipment Ministry - Canada Ministry of Health, kungakhathaliseki ukuthi akhiqizwa endaweni noma angeniswe kwamanye amazwe.

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Enqubweni yokuhlola ye-CMDCAS yaseCanada, ubufakazi kumele buhlangabezane nezidingo zesistimu yokuphatha ikhwalithi ejwayelekile i-ISO 13485/8:199 noma i-ISO 13485:2003 futhi kumele buhlangabezane nezinga elidingekayo yiMithetho Yedivayisi Yezokwelapha yaseCanada.

 

Uma ufuna ukuphumelela isitifiketi sedivayisi yezokwelapha yaseCanada, imishini yezokwelapha kufanele ibe ngcono ngekhwalithi nangobuchwepheshe futhi ikwazi ukumelana nokuhlolwa okuhlukahlukene. Impumelelo ebushelelezi kwisitifiketi se-CMDCAS saseCanada iphinde yaqinisekisa ikhwalithi yethu yobuchwepheshe enhle kakhulu ye-probe yethu yokushisa futhi.

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I-Probe Yokushisa Komgodi

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I-Probe Yokushisa Komzimba

 

Zinikele ekucwaningeni nasekuthuthukiseni, ekukhiqizeni nasekuthengiseni izinto zokwelapha ezisezingeni eliphezulu, sizimisele ngempela!

 

Yenza abasebenzi bezokwelapha babe lula, abantu babe nempilo enhle

 

Sihlala sizama konke okusemandleni ethu

Isikhathi sokuthunyelwe: Meyi-26-2017

QAPHELA:

1. Imikhiqizo ayikhiqizwanga futhi ayigunyaziwe ngumkhiqizi wemishini yokuqala. Ukuhambisana kusekelwe ezicacisweni zobuchwepheshe ezitholakala emphakathini futhi kungahluka kuye ngemodeli yemishini kanye nokucushwa kwayo. Abasebenzisi belulekwa ukuthi baqinisekise ukuhambisana ngokuzimela. Ukuze uthole uhlu lwemishini ehambisanayo, sicela uxhumane nethimba lethu lenkonzo yamakhasimende.
2. Iwebhusayithi ingabhekisela ezinkampanini zangaphandle kanye nemikhiqizo engahlobene nathi nganoma iyiphi indlela. Izithombe zomkhiqizo zenzelwe izinjongo zokubonisa kuphela futhi zingase zihluke ezintweni zangempela (isb., umehluko ekubukekeni kwesixhumi noma umbala). Uma kwenzeka noma yikuphi ukungafani, umkhiqizo wangempela uzonqoba.