Under EU MDR and before the FDA, clinical evidence is neither a single document nor a single moment: it is a Clinical Evaluation Plan that defines the clinical question, evidence standards and strategy, followed by investigation, reporting and post-market follow-up.

This 16-hour Professional Certificate Course introduces the EU MDR Annex XIV framework and the MEDDEV 2.7/1 Rev. 4 methodology, the components and structure of the Clinical Evaluation Plan, study design and population (endpoints, inclusion/exclusion), the Statistical Analysis Plan and its integration with risk management under ISO 14971.

The Introductory course prepares participants for the Advanced level (RAQ-670-A), where the investigation plan and protocol, informed consent, the Clinical Study Report and post-market clinical follow-up are developed in depth.

The Introductory course gives clinical-affairs and regulatory professionals the Annex XIV and CEP foundation on which every clinical-evaluation dossier and CE-mark review depends.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.