Medical management and compensation related to clinical investigation (1) Where any ...

PROVIDED ALSO that, the results of clinical investigation may not be required ta be s ...

Ethics Committee This section shall document that the clinical investigation was cond ...

Paediatrics: (a) The timing of pediatric studies in the medical device development pr ...

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

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

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

Preclinical testing Summary of preclinical testing that has been performed on the i ...