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7.4 Biological safety: (i) The dossier should contain a list of all materials of animal or...

2023-09-16T04:47:13

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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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(b) the intended user (lay person or professional); (c) a general description of the princ...

2023-09-16T05:31:26

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

2023-09-16T04:43:15

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(f) animal studies that provide direct evidence of safety and performance of the device, e...

2023-09-16T04:41:25

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(f) animal studies that provide direct evidence of safety and performance of the device, e...

2023-09-14T05:12:50

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e) a description of the accessories, other medical device and other product that are not m...

2023-09-14T04:56:32

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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-14T04:54:40

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