7.3.2 Design and development inputs: Inputs relating to product requirements shall be ...

7.3.3 Design and development outputs: The outputs of design and development shall be ...

4.0 Design and manufacturing information: 4.1 Device Design: The dossier should conta ...

(d) records needed to provide evidence that the realisation processes and resulting p ...

(d) records needed to provide evidence that the realisation processes and resulting p ...

5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensur ...

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

(iv) ensure that manufacturing site and products comply with prescribed standards re ...