Additional elements, which may be required (a) Statement of foreseeable circumstance ...

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

If the medical device is intended to treat serious or lifethreatening diseases, occu ...

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

Justification for the design of the clinical investigation Justification for the desi ...

Medical management Where any participant is injured on account of his participation i ...

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

Medical management Where any participant is injured on account of his participation i ...