Qserve’s EU MDR first aid app will be available to download worldwide from May 15th, 2017. The new EU Medical Device Regulation ensures that the Medical Device sector will further need to increase its compliance level. Therefore, Qserve designed a dedicated app that can be used as a tool to assess a company’s EU-MDR implementation status and provide next steps on the road to compliance.
Dr. Gert Bos, Executive Director and Partner says: ”As a global leading consultancy company, we see it as our mission to support medical device manufacturers with a practical approach in obtaining their future MDR certification. For this reason, we have worked on this app to be ready before the transition period. This app will help manufacturers to assess their status, monitor progress toward full compliance and create awareness within their organization for these significant changes in the EU regulations.”
A quick scan of critical impact elements identifies key MDR changes and actions for your company’s devices. The EU-MDR First Aid app offers you the opportunity to do a quick compliance scan within minutes. This tool for medical device manufacturers works on a questionnaire that gives a basic insight in your position and compares this relative to other manufacturers using this app.
Nine sections are covered and include relevant questions. A simple yes or no will lead you through the questionnaire. Finally, a graphic per subject will be displayed, with a score reflecting your current position. Also, next steps are given regarding where to focus and how to progress your status toward full implementation.
During the transition period, you can update your current status compared with market status. You can update the tool as often as you like during the whole period of implementation. You can share the outcome as a compliance report with your colleagues to create awareness within your organization. The report can also be shared with Qserve, in case you need assistance with implementing the EU MDR.
You can download the Qserve First Aid app for free in the Apple App Store or Google Play Store
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