(ii) the applicant shall provide adequate space having regard to the nature and numbe ...

(ii) the applicant shall provide adequate space having regard to the nature and numbe ...

INFORMATION TO BE SUBMITTED ALONG WITH THE APPLICATION 1. Design Analysis data inclu ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...

BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. ...

BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. ...

2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationa ...

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