Clinical Evidence
| Page | Covers |
|---|---|
| Clinical Evaluation Overview | CER structure, MedDO Annex XIV, MDCG guidance in Switzerland |
| Clinical Investigations (ClinO-MD) | ClinO-MD (SR 810.305), Swissmedic authorisation, BASEC ethics approval |
| Performance Evaluation (IVD) | IVDO Annex XIII, performance study types, MDCG 2022-2 applicability |
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