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(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinic...

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Design and development review: At suitable stages, systematic reviews of design and develo...

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7.3.4 Design and development review: At suitable stages, systematic reviews of design and ...

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

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1.1 Introductory descriptive information on the in vitro diagnostic medical device, the in...

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

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

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

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

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