MUNICH, April 15, 2014 /PRNewswire/ --
**Ensure compliance with the new FDA and European Rules on Unique Device Identifiers**
The FDA released the Final Rule on Unique Device Identifiers (UDIs) for all medical devices being sold or shipped into the US, and companion guidelines from the European Commission are due soon for Europe.
In light of this, Healthcare IQ would like to stress the importance of the FDA Final Rule - do you know how to comply? Or what the consequences are for non-compliance?
Get insider information from the FDA and European Commission - have all your questions answered straight from the horses mouth, at the 2nd Annual Medical Device UDIs & Traceability Forum in Munich on 21-22 May. Covering essential topics on how to help you comply:
- What's needed for compliance?
- What's the penalty for non-compliance, and how will this be enforced?
- What Class I and II manufacturers should be doing now to prepare for their deadlines
- The Class III compliance crisis - time is running out!
- Implementing a UDI project successfully & avoiding pitfalls
Most manufacturers have had various barcoding and labelling activities for years, but the new regulations mean many will have to not only bring their printing and labelling technologies up to compliance, but also their Master Data Management for interoperability with the GUDID (database). Even if you're already prepared for the new labels, the biggest challenge is still to come in your Master Data Management, infrastructure and interoperability. Don't fall into the trap of thinking you've covered your bases and have nothing left to do!
We have several talks on master data and GUDID, including the FDA and Medtronic, as well as a half-day workshop, to get you prepared.
The forum will cover all you need to know, plus hearing direct from the FDA and European Commission will help clear up any outstanding questions you may have.
SOURCE Medical Device UDIs & Traceability Forum