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(i) for medical devices intended to emit ionizing radiation, information on radiation sour...

2023-09-14T04:57:28

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Abbreviated terms and definitions A list of abbreviated terms and definitions of specializ...

2023-07-12T05:25:54

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7.3.2 Design and development inputs: Inputs relating to product requirements shall be dete...

2023-10-13T05:18:32

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5.6.2 Review input: The input to management review shall include information on— (a) resul...

2023-10-11T04:40:16

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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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(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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Prohibition of disclosure of information Except for the purpose of official business or wh...

2023-08-05T05:47:15

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Investigational medical device and methods 6.1 Investigational medical device description ...

2023-07-12T05:11:13

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