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design analysis data

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

design analysis data

Monitoring plan General outline of the monitoring plan to be followed, including acce ...

design analysis data

PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR ...

design analysis data

Justification for the design of the clinical investigation Justification for the desi ...

design analysis data

REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE ...

design analysis data

(f) animal studies that provide direct evidence of safety and performance of the devi ...

design analysis data

(f) animal studies that provide direct evidence of safety and performance of the devi ...

design analysis data

Investigational medical device and methods 6.1 Investigational medical device descrip ...