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Gap Analysis to the new Medical Device Regulation EU 2017/745 (MDR)

This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now!

Manufacturers across the world are not only planning to transition to the MDR they are also transitioning to the new QMS standard ISO13485:2016, which must be completed in 2019. Notified Bodies are already quoting extended lead times due to shortages of staff and other operational issues, it makes sense therefore to commence your planning process, don’t get caught out!

With our team of experts Advena can help and guide you through the transition process from MDD to MDR.

Our comprehensive MDR gap analysis, reviewing your current technical file, will highlight gaps, deficiencies or non-compliances in your documentation and processes, this will be presented via our in-depth gap analysis report, with suggestions and recommendations on how to fix these in readiness for your first MDR audit.

For more details please contact our team:

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