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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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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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4.2.3 Control of documents : Documents required by the quality management system shall be ...

2023-10-10T04:32:42

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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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(i) a firm means change from proprietorship to partnership including Limited Liability Par...

2023-08-26T07:12:44

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

2023-07-11T06:00:29

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

2023-07-11T04:32:16

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