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

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ABOUT US Accredited Consultants The clients receive outstanding value from accredited Cons...

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

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

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

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

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

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

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Control of design and development changes: Design and development changes shall be identif...

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