By Stefano Rizzo
The U.S. Food and Drug Administration has announced finalization of a new new system to identify medical devices. The new requirements for medical devices to comply with the FDA’s unique device identification system (UDI) highlights a point we at Polarion have been interested in for some time now: the convergence of ALM and PLM*.
UDI compliance will not only necessitate planning in the requirements and design phases, but also tracking through implementation, testing, and onward into the manufacturing process. Polarion Software’s Medical Device and ALM solutions are already well suited to the ALM-PLM convergence, which I like to call “PALM”. (If you would like to begin learning more about it, let me suggest our free whitepaper, below).
We’ll be blogging more on the FDA’s UDI system in the near future, so stay tuned to the feed if you’re interested in learning more about how Polarion can help medical device manufacturers plan for and meet UDI requirements.
* ALM: Application Lifecycle Management PLM: Product Lifecycle Management