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Device description and product specification, including variants and accessories 2.1 The d...

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CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the clinical...

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Procedural issues A system shall be established to enable cross-referencing of CRFs and C...

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Overall synopsis of the clinical investigation A summary or overview of the clinical inves...

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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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Animal studies: (i) Where studies in an animal model have been undertaken to provide evide...

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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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an undertaking from the manufacturer stating that the proposed device is a Class A non-ste...

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