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3.13 Quality audit means a systematic, independent examination of a manufacturer's quality...

2023-10-09T05:43:46

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Finished device means any device or accessory to any device that is suitable for use or ca...

2023-06-28T10:42:43

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Other information: This section of PSUR shall include details about signals and Risk Mana...

2023-07-10T08:57:31

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Other information: This section of PSUR shall include details about signals and Risk Manag...

2023-07-08T06:52:21

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POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additi...

2023-10-30T06:18:22

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(iii) a table compiling all observed device deficiencies that could have led to a serious ...

2023-07-12T05:23:23

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General (i) Case Report Forms are established to implement the clinical investigation pla...

2023-07-11T05:57:34

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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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Publication policy (a) Statement indicating whether the results of the clinical investiga...

2023-05-30T04:54:00

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