Meyi 25, 2017, ukuhlolwa kwezinga lokushisa okusebenzisekayo kwezokwelapha kwacwaningwa ngokuzimela futhi kwathuthukiswa yi-Shenzhen Med-linket Medical Electronics Co., Ltd. iwine isitifiketi saseCanada CMDCAS

Ingxenye yesithombe-skrini sesitifiketi sethu se-CMDCAS

Kubikwa ukuthi isitifiketi sedivayisi yezokwelapha yase-Canadian sihluka esitifiketini sase-US (FDA) esisingathwa ngokuphelele uhulumeni ekubhaliseni umkhiqizo kanye nokubuyekezwa kukahulumeni endaweni (ukubuyekezwa kwe-GMP), siphinde sihluke kwesiseYurophu (isitifiketi se-CE) esigunyazwe ngokuphelele yinkampani yangaphandle, i-CMDCAS isebenzisa uhlelo lwekhwalithi olugunyazwe ukubhaliswa kukahulumeni kanye nokubuyekezwa okuvela eceleni. Umuntu wesithathu kufanele futhi agunyazwe yi-Canadian Medical Device.

Zonke izisetshenziswa zezokwelapha ezithengiswa emakethe yaseCanada zidinga ukuthola imvume ku-Canadian Medical Equipment Ministry - Canada Ministry of Health, kungakhathaliseki ukuthi ikhiqizwa endaweni noma ingeniswa kwamanye amazwe.

Enqubweni yokucwaninga ye-Canadian CMDCAS , ubufakazi kufanele buhlangabezane nezimfuneko zesistimu yokuphatha ikhwalithi evamile ISO 13485/8:199 noma ISO 13485:2003 futhi kufanele buhlangabezane neziqu ezidingwa yi-Canadian Medical Device Regulations.

Uma ufuna ukudlula ngempumelelo isitifiketi sedivayisi yezokwelapha yase-Canada, okokusebenza kwezokwelapha kufanele kube phezulu ngekhwalithi nobuchwepheshe futhi kungamelana nokuhlolwa okuhlukahlukene. Impumelelo ebushelelezi yesitifiketi se-Canadian CMDCAS iqinisekise ikhwalithi yethu ephezulu kakhulu yobuchwepheshe yokuhlola izinga lokushisa futhi.

I-Cavity Temperature Probe

I-Body Temperature Probe

Sizinikele ekucwaningeni ngokuzimela futhi sithuthukise, sikhiqize futhi sidayise izinsiza zokwelapha ezisezingeni eliphezulu, sizimisele ngempela!

Yenza abasebenzi bezokwelapha babe lula, abantu babe nempilo

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