Über die Veranstaltung

Clinical Evaluation:
- MDR Requirements & Intended Purpose
- Clinical Evaluation Plan
- Clinical Evaluation Report
- Types of Clinical Investigations & Requirements
- Post-Market Surveillance & Post-Market Clinical Follow-up
- Practice Exercise: Planning of systemic literature search
- Practice Exercise: Identification of patient data
- Practice Exercise: Appraisal of pertinent data
Biological Evaluation:
- MDR Requirements & ISO 10993 Series
- Strategy: Biological Evaluation Plan, Testing and Risk Assessment, Biological Evaluation Report

Description:
This course provides a comprehensive overview of clinical and biological evaluation requirements under the EU MDR, including intended purpose, clinical evaluation planning, reporting, and applicable investigation types. Participants will explore post-market surveillance and post-market clinical follow-up, and gain practical experience through exercises on systematic literature searches, identification of patient data, and appraisal of pertinent data. The course also covers biological evaluation in accordance with the ISO 10993 series, including strategic planning, testing, risk assessment, and preparation of the biological evaluation report.