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Customer complaint—Written, electronic or oral communication that alleges deficiencies rel...

2023-06-28T10:39:13

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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3.8 Design output means the results of a design effort at each design phase and at the end...

2023-10-09T05:41:57

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3.6 Component means any raw material, substance, piece, part, software, firmware, labeling...

2023-10-09T05:41:06

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(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of eval...

2023-10-05T05:38:09

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19.0 Clinical Evidence: The device master file should contain the Clinical Evidence, Evalu...

2023-10-05T05:32:49

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3.0 Labelling: The dossier should typically contain a complete set of labeling associated ...

2023-09-14T04:58:20

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Medical devices requiring clinical investigation but claiming substantial equivalence to ...

2023-07-31T06:17:24

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REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE FOR ...

2023-07-06T05:40:04

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