PRISYM ID Speaks and Exhibits at the 8th EU Medical Device Regulatory Affairs Conference
After the successful presentation we had in July at the 2nd Annual EU MDR Implementation Conference in Arlington, we are proudly sponsoring and speaking about EU MDR’s impact on labels at the 8th EU Medical Device Regulatory Affairs Conference 18-19 September 2018, in Brussels, Belgium.
Our presentation; which was described by the delegates in Arlington as: “Best of the whole 2 days!”, “Excellent information shared", "Excellent!", "Best content"; will be led by Gert Zeilstra, and will take place during the second day, from 11:15 am covering:
- Label provisions comparison MDR vs MDD & AIMDD
- Comparison of EU MDR & FDA UDI
- Medical Device Label – Before and After EU MDR
- Touch Your Labels Once Strategy
- Labelling that can Adapt to a Changing World
Under the EU MDR, the importance of providing end-users with critical information for the safe and proper use of a medical device is taken to a higher level than with the MDD. Requirements span new end-user and device-specific data impacting clinical and quality operations, new label formats, as well as any published information now considered labelling material, impacting marketing.
With such a prominent position given to labelling in the EU MDR, regulatory professionals must secure a clear interpretation of mandates to efficiently reach compliance as well as understanding the technical challenges EU MDR brings to the organisations.
If you will be in Brussels for this event, please attend our session and stop by our stand for a copy of our new Infographic: Medical Device Label - Before and After EU MDR and for more information about PRISYM ID and how our labelling solution can help you to:
Improve FDA & EU compliance
Minimize risks & product recalls
Increase traceability & auditability and more…