AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers
Summary
The AssurX solution aligns business logic with the most up-to-date MIR template as published by the European Commission (EC). The AssurX EU MDR solution enables medical device manufacturers to automate MIR documentation and submission in accordance with vigilance guidelines and reporting time frames. As of January 1, 2020, manufacturers marketing their devices in the EU should be utilizing the EU Manufacturing Incident Report (MIR) form for medical device vigilance reporting.” Fully configurable forms, dashboards and reports, and templates provide a solid starting point for implementing best practice processes that meet specific business needs. “AssurX designed this solution to centralize the required data that may be dispersed across your technical ecosystem,” added McArdle. “You can empower your cross-functional teams to strengthen engagement and commitment for quality today and be aligned for electronic submissions when the portal opens.” AssurX EU MDR incident report automation can integrate with the AssurX platform as well as other business applications or run autonomously as quality and compliance systems are in the designed and implementation stages.
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