EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

The main purpose of the EU Medical Device Vigilance System is to improve the protection of health and safety of patients and others by reducing the likelihood of incident recurrence. Postmarket surveillance and reporting under EU MDR will be exponentially more in-depth as it expands to focus on the entire life cycle of the product. EU Manufacturing Incident Reports (MIR) require extensive information submissions, from market distribution data to clinical and detailed failure data, to cause investigation and conclusions. While much of the information submitted to EUDAMED will come from ancillary systems in the manufacturing chain, a significant portion of data will come directly from your quality management system (QMS). See how AssurX helps your organization for Implementing a MIR-ready complaint management solution.

This webinar shares strategies for efficiently managing postmarket surveillance challenges faced by medical device manufacturers marketing devices in the EU.

Key focus areas include:

  • Review the current state of EU MDR readiness
  • The complaint management system as a key process in QMS for EU MDR market surveillance
  • Leveraging a risk-based approach utilizing decision trees to support post-market reportability
  • MIR requirements today and post-EUDAMED rollout
  • Leveraging UDI data to support the MIR form
  • Frequently asked questions by your peers

Watch a brief demonstration of how a quality management system can populate MIRs for submission with data extracted from complaint and UDI records.

We're proud to keep good company

GOJO Logo | AssurX Quality Management Software
Talking Rain Logo | AssurX Quality Management Software
Dollar Tree Logo | AssurX Quality Management Software
Dendreon Logo | AssurX Quality Management Software
Energy Harbor Logo | AssurX Quality Management Software
Xyngular Logo | AssurX Quality Management Software