EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
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Online Event
Date
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Description
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 the current state of EU MDR readiness
- The complaint management system is 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.
Register today! https://register.gotowebinar.c...
Organiser
FAQ
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EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution
From Free