The AssurX EU MDR Solution Automates the Process of MIR Submissions
European Union Medical Device Regulation (EU MDR) requires medical device manufacturers to meet significantly higher quality and safety standards than in the previous Medical Device Directive (MDD). Post-market vigilance requirements present process challenges that require modern technology solutions.
AssurX electronic reporting solution automates the EU Manufacturer Incident Reporting (MIR), enabling timely post-market reporting of applicable medical device vigilance incidents. Post-market requirements outlined in the EU MDR carry significant process challenges and procedure updates.
The AssurX EU MDR solution aligns business logic with the most up-to-date MIR template published by the European Commission (EC) and automates the documentation and submission under vigilance guidelines and reporting time frames.
AssurX Manufacturer Incident Reporting (MIR) submission data can be connected
to any AssurX QMS process that requires the compilation and evaluation of the product
EU MDR Readiness Check: Clinical Data, Definitions and Documentation
This eBrief provides a brief list of items to consider before embarking on a design change to a medical device planned for distribution to one of the European Union member states.
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