Two years ago I was working on BSI from a Supply Chain perspective. It was interesting in the fact that we had to understand different countries regulations in the European Union. Some required regulatory approval to receive product whereas some countries had less stringent rules for receiving product. Also, it was interesting seeing the importance from a legal standpoint of the impact of an IFU.

What Regulatory projects have you worked on? For example, have you worked on any aspect of BSI or UDI? If so, relating it back to last weeks module on Project Management, what issues or challenges have you run across on these projects?