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.
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