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

2023-10-13T05:21:41

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The manufacturer shall ensure that changes to documents are reviewed and approved either b...

2023-10-10T04:34:14

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4.2 Documentation requirements 4.2.1 General: The quality management system documentation ...

2023-10-10T04:28:46

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What are the requirements for import of Class-A/B/C/D In Vitro Diagnostic Medical device ...

2023-10-31T12:24:26

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

2023-10-18T05:09:40

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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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If the product is cleaned in accordance with clause (a) or clause (b) above, the requireme...

2023-10-17T05:28:57

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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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