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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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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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7.5.3.1 Identification The manufacturer shall identify the product by suitable means thro...

2023-10-17T05:39:59

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Records of validation shall be maintained. 7.5.2.2 Particular requirements for sterile med...

2023-10-17T05:39:45

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The manufacturer shall maintain records of the process parameters for the sterilization pr...

2023-10-17T05:35:51

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The manufacturer shall establish and maintain a record for each batch of medical device or...

2023-10-17T05:27:04

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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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The manufacturer shall establish arrangements for these processes including, as applicable...

2023-10-17T05:36:04

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