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DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An execu...

2023-06-27T05:10:11

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Medical Device Complaints and Field Safety Corrective Action: (i) arrangements for the han...

2023-06-26T07:16:27

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Sponsor or manufacturer Name and address of the sponsor or manufacturer of the investigat...

2023-07-10T11:03:09

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INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data including,...

2023-07-10T09:00:44

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Improvement General: The manufacturer shall identify and implement any changes necessary t...

2023-07-06T05:34:44

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Control of monitoring and measuring devices The manufacturer shall determine the monitorin...

2023-07-06T04:57:18

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Preservation of product: The manufacturer shall establish documented procedures or docume...

2023-07-06T04:55:25

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Customer communication: The manufacturer shall determine and implement effective arrangeme...

2023-07-05T05:19:40

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Information required to be submitted for the in vitro diagnostic medical device: (1) The ...

2023-06-28T06:57:14

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