AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers
Solution helps ensure information accuracy, timeliness of submissions and full transparency
MORGAN HILL, Calif., February 6, 2020 (Newswire.com) - AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced the availability of its Manufacturing Incident Report (MIR) Solution for EU MDR incident report automation. 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. It is pre-configured to conform to the quality and compliance standards of the EU. AssurX EU MDR provides a timely solution to automate the completion of MIRs electronically. Teams can export the report in readable formats to enable efficient review by internal teams or even their Authorized Representative.
“While the pace of discussion has slowed with the two-year delay of EUDAMED, there is no delay in the requirements for electronic reporting of adverse events,” explained Stephanie McArdle, VP of Product Management for the Life Sciences Industry at AssurX. “The reality is that the regulations and requirements remain intact, including implementation timelines. 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. of each incident.
The Manufacturing Incident Report (MIR) Solution for EU MDR is available today. For more information, connect with AssurX today.
Source: AssurX, Inc.