Meyi 25, 2017, izilimo zokushisa ezisebenziseka kalula ziphenya ngokuzimela futhi zakhiwa nguShenzhen Med-Linket Medical-Linket Medical-Linklet Electronics Co, Ltd. Won.

Ingxenye yesikrini sesikrini se-CMDCAS

Kubikwa ukuthi ukuqinisekiswa kwedivaysi yaseCanadian kwezokwelapha kuhlukile kwi-US (FDA) isitifiketi esisisingathwe ngokuphelele nguhulumeni ekubhaliseni umkhiqizo kanye nokubuyekezwa kukahulumeni (i-GMP), futhi kuyahlukahlukana ne-European (CE isitifiketi) esiqinisekiswa ngokuphelele ngumuntu wesithathu , I-CMDCAS isebenzisa uhlelo lwekhwalithi oluqinisekiswe ukubhaliswa kukahulumeni kanye nokubuyekezwa kweqembu lesithathu. Umuntu wesithathu kumele futhi avunyelwe yiCanada Medical Medical.

Wonke amadivaysi ezokwelapha athengiswa emakethe yaseCanada kudingeka athole imvume emnyangweni wezokwelapha waseCanada - uMnyango Wezempilo waseCanada, noma ngabe akhiqizwa endaweni yangakini noma angeniswa.

Ezinhlelweni zokucwaninga kwama-CACanadian CMDCAS, ubufakazi kufanele buhlangabezane nezidingo zohlelo lokuphathwa kwekhwalithi ejwayelekile ISO 13485/8: 199 noma i-ISO 13485: 2003 futhi kufanele ihlangabezane nezinga elidingekayo yi-Canadian Medical Recarms.

Uma ufuna ukudlula ngempumelelo isitifiketi sedivayisi ye-Canadian Medical ye-Medical Medical, imishini yezokwelapha kufanele ibe ephakeme ngekhwalithi nobuchwepheshe futhi ingakwazi ukumelana nokuhlolwa okuhlukahlukene. Impumelelo ebushelelezi ekuqinisekisweni kwesitifiketi seCanada CMDCAS iqinisekisa ikhwalithi yethu yezobuchwepheshe ephezulu kakhulu yokushisa kwethu izilinganiso.

I-Cavity Temperature Prope

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