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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.

The new EU Manufacturing Incident Report (MIR) v 7.2.1 requires extensive information, 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).


Join us for a one-hour webinar, EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution, that will focus on the requisite functionality of a QMS for any company manufacturing and/or marketing medical devices in the EU in the era of MDR.

Key focus areas include:

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

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

DATE:          
Tuesday, February 23, 2021

TIME:           
9:00 AM PST 
11:00 AM CST
12:00PM EST
 5:00 PM GMT

DURATION:   
One Hour


Can’t make it? Register and we'll send you a link to view the webinar recording.

www.assurx.com   I   info@assurx.com   I   408.778.1376