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Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evalu...

2023-10-13T05:22:38

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As part of design and development validation, the manufacturer shall perform clinical eval...

2023-11-04T06:17:57

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General The manufacturer shall establish documented procedures for traceability. Such ...

2023-10-18T11:20:49

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General The manufacturer shall establish documented procedures for traceability. Such p...

2023-10-18T11:17:08

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General The manufacturer shall establish documented procedures for traceability. Such p...

2023-10-18T11:12:23

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7.5.4 Customer property: The manufacturer shall exercise care with customer property while...

2023-10-17T06:58:09

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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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7.3.6 Design and development validation: Design and development validation shall be perfor...

2023-10-13T05:21:41

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7.3.1 Design and development planning: The manufacturer shall establish documented procedu...

2023-10-13T05:16:35

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