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

Metrological traceability of calibrator and control material values Where applicable, ...

Essential principles checklist: (i) The dossier should contain the following:— (a) th ...

3.18.2 Design validation means establishing by objective evidence that device specifi ...

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

7.3.6 Design and development validation: Design and development validation shall be p ...

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...

1.2 Information regarding sterilization of the device (whether it is sterile or non-s ...