European Union Medical Device Regulation (EU MDR) is requiring the medical device manufactures to meet the criteria of higher standards of any quality and being safe enough as compared to previous Medical Device Directive (MDD). Post-market vigilance basic requirements highlight all the major challenges of the project that somehow require the modern technology solutions.
AssurX electronic solution simply automates the entire EU Manufacturer Incident Reporting (MIR). This will be enabling the timely series of post-market reporting of different applicable medical device vigilance incidents.
The AssurX EU MDR Software solution will be aligning some of the basic logic related to the updated MIR template as it has been published by the European Commission (EC). It also automates the documentation all along with the submission as in accordance with some vigilance guidelines as well as reporting time frames.
Important Features of AssurX Automated MIR Submission Solution
The AssurX EU MDR solution is completely pre-configured to hence conform in view to the quality along with the compliance standards of any EU. It also eliminates the basic need for the manual lookup. The reminders will be investigating on top pace for some tighter reporting deadlines.
It brings about the efficient and much centralized submissions. AssurX will make sure the accuracy and timeliness of the submissions with the range of different features. This will come across with the fuller transparency in relation with any incident. Each single incident will be becoming the part of basic device record in which it will be capturing some basic information. This will include determination of reportability as well as justification of any sort of non-reportable events.
Automated EU MDR Solution will be providing a range of real-time tracking of reportability in the middle of complete auditing trail. Generate PDF or even XML output for the sake of submission as per according to the new published guidelines for the Manufacturer Incident Report (MIR) for some Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD).
Right under the latest EU MDR, post-marketing events will be requiring an effortless synergy to different other areas within any organization. AssurX software can initially run all alone or it can also be integrated with some of the AssurX post-market surveillance quality management system. This is done for the sake of unmatched visibility in any device history.
AssurX Professional Services will be providing a proven set of implementation methodology for accelerating the solution deployment along with the integration needs. It will also assist you in maximizing the range of validation efficiencies that has been linked with some future enhancements as well as configuration changes by means of re-validating your system.
Important Benefits of AssurX EU MDR Solution
MIR submission will complete minimize all your risks. You can eventually collect the detailed and quantifiable data for the purpose of trending in some centralized repository. You can also integrate with some additional QMS processes for some downstream issue management. This will include within investigations, as well as CAPA and even change management.