Webinar Details

Wednesday, July 22, 2026 · 15:00

About

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 market deficiencies, including inconsistent data collection practices, inadequate audit trails, poor documentation of data provenance, and the use of general-purpose tools that fail to meet regulatory standards for clinical-grade data management.

To address these critical challenges, 1MED is pleased to invite you to an expert-led webinar examining the core regulatory requirements governing clinical data collection under MDR and ISO 14155.

Complementing this operational view, BSI will provide the Notified Body standpoint on what differentiates standard data from defensible regulatory evidence. They will discuss how evidence is evaluated regarding traceability, data integrity, and its direct linkage to critical regulatory documentation like Clinical Evaluation Reports (CER), PMCF reporting, risk management, and SSCP updates.

Key Discussion Topics:

• What the MDR and ISO 14155 actually require from your clinical data.
• Where manufacturers are failing: non-conformities from real assessments.
• Generating defensible clinical evidence in PMCF and Real-World Data (RWD) contexts.
• Leveraging purpose-built digital infrastructures for compliant clinical data collection.

Who Should Attend

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

Secure your spot to gain practical insights on how to strengthen your clinical evidence strategy and reduce regulatory risks.

REGISTER TODAY