How to Ensure Data Quality and Reliability in Clinical Trials and PMCF under MDR

As regulatory expectations under the Medical Device Regulation (MDR) continue to evolve, Notified Bodies are placing greater emphasis on the quality, traceability, and reliability of clinical evidence generated through clinical investigations and Post-Market Clinical Follow-up (PMCF) activities. Recent conformity assessments have revealed recurring deficiencies, including inconsistent data collection practices, inadequate audit trails, poor documentation of data provenance, and the use of general-purpose tools that may not meet regulatory requirements for clinical-grade data management.

This webinar will examine the key regulatory requirements governing clinical data collection under MDR and ISO 14155, highlighting the most common non-conformities identified during audits and assessments. Attendees will gain practical insights into current regulatory expectations for generating structured, continuous, and verifiable clinical evidence, particularly in the context of PMCF and real-world data. The session also explores how purpose-built digital platforms can support compliant, transparent, and high-quality clinical data collection, helping manufacturers strengthen clinical evidence strategies and reduce regulatory risk.

Agenda
- Introduction to Presenters
- What MDR and ISO 14155 Actually Require From Clinical Data
- Where Manufacturers Are Failing: Non-Conformities From Real Assessments
- Generating Defensible Clinical Evidence in PMCF and Real-World Data Contexts
- Digital Infrastructure for Compliant Clinical Data Collection
- Q & A

Who Should Attend
- Head of Regulatory Affairs
- Director of Clinical Affairs
- Head of Post-Market Surveillance
- Quality Management System (QMS) Manager
- Clinical Data Manager