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

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

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

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PARAMETERS FOR CLASSIFICATION FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. Basic principles ...

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PARAMETERS FOR CLASSIFICATION OF MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL D...

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