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

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

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

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

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

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Identification: The manufacturer shall identify the product by suitable means throughout ...

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

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

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The manufacturer shall ensure the adequacy of specified purchase requirements prior to the...

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