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7.0 Analytical Studies: The statements and descriptions in the following sections refer to...

2023-10-03T05:22:57

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

2023-09-14T05:01:44

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Details of suspected adverse device reaction(s): (a) Full description of reaction(s) inclu...

2023-07-12T04:40:52

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Analytical Studies: The statements and descriptions in the following sections refer to all...

2023-06-28T06:37:59

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The essential principles checklist should incorporate a cross-reference to the location of...

2023-06-27T04:51:46

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Procedural issues A system shall be established to enable cross-referencing of CRFs and CI...

2023-05-30T04:56:56

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