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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

2023-09-16T04:43:15

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BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. Rece...

2023-07-10T08:59:52

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BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. Rece...

2023-07-10T08:59:44

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e) a description of the accessories, other medical device and other product that are not m...

2023-09-14T04:56:32

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Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evalu...

2023-10-13T05:22:38

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1.5 It is emphasized that the quality management system requirements specified in this Sch...

2023-10-06T04:29:11

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2. Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) qual...

2023-09-12T05:11:41

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DESIGN ANALYSIS DATA Design Analysis Data for a medical device shall include the following...

2023-07-10T08:57:56

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

2023-07-06T04:55:25

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