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

Subjects (a) Inclusion criteria for subject selection. (b) Exclusion criteria for sub ...

INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed cons ...

4. Equipment: (i) brief description of major production and quality control laborato ...

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

1.1 Introductory descriptive information on the in vitro diagnostic medical device, t ...

7.3.4 Design and development review: At suitable stages, systematic reviews of design ...

INVESTIGATOR'S BROCHURE (IB) 1. General 1.1 Introduction Information Brochure shall c ...