Objective
Objectives are stated in the CIP and lead to the endpoints and hypotheses. Secondary objectives are assessed with secondary endpoints.
main purpose for conducting the clinical investigation (3.8)
ISO 14155:2020, clause 3.37
Objectives are stated in the CIP and lead to the endpoints and hypotheses. Secondary objectives are assessed with secondary endpoints.
main purpose for conducting the clinical investigation (3.8)
ISO 14155:2020, clause 3.37