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Sponsored Presentation

Sponsored Presentation - Round 1: How to Ensure Data Quality and Reliability in Clinical Trials and PMCF under MDR

Thursday, May 7, 2026
13:30 - 13:55 WEST
Location: Exhibition Hall - Discover!

Presented by 
Description The MDR as well as the harmonized standard ISO 14155 for clinical investigations of medical devices for human subjects and the currently planned update of both of those files set up complex requirements on clinical investigations and PMCF activities.

Learning Objectives:

  • Identify the key regulatory requirements of MDR and ISO 14155 for clinical investigations and PMCF activities.
  • Recognize and evaluate the most common non-conformities in clinical data collection, including gaps in audit trails, data provenance, and use of non-compliant tools.
  • Apply best practices for implementing structured, traceable, and regulator-ready clinical data collection processes using validated digital platforms.