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Customer complaint—Written, electronic or oral communication that alleges deficiencies rel...

2023-06-28T10:39:13

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Definitions In these rules, unless the context otherwise requires, — (a) "academic clinica...

2023-07-13T09:22:58

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Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investigation...

2023-07-11T05:59:17

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Subjects (a) Inclusion criteria for subject selection. (b) Exclusion criteria for subject ...

2023-07-11T04:39:40

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CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies the con...

2023-07-11T04:28:48

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INVESTIGATOR'S BROCHURE (IB) 1. General 1.1 Introduction Information Brochure shall contai...

2023-07-10T11:00:36

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All relevant clinical and non-clinical safety data will cover only the period of the repor...

2023-07-08T06:02:56

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Post Marketing Surveillance: (i) Subsequent to approval of an Investigational medical devi...

2023-07-07T04:40:27

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Analytical performance characteristics: 9.1 Accuracy of measurement: This section should d...

2023-06-28T06:39:47

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