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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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3.18.2 Design validation means establishing by objective evidence that device specificatio...

2023-10-09T05:45:47

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3.16 Rework means action taken on a non-conforming product that will fulfill the specified...

2023-10-09T05:44:44

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In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to cl...

2023-09-09T08:54:37

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Ethics Committee This section shall document that the clinical investigation was conducted...

2023-07-12T05:21:00

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In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to cla...

2023-06-23T05:54:23

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Ethics Committee This section shall document that the clinical investigation was conducted...

2023-06-02T04:55:31

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In vitro diagnostic medical devices for blood grouping or tissue typing (a) Subject to cla...

2023-05-18T06:21:06

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Guidelines for uploading data for Manufacturing and Formulation data / Written Confirmatio...

2023-04-25T05:58:45

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