Category Archives: Medical Device Innovation

Lifting the Lid on UDI’s Pandora’s Box

Pandoras BoxWhile working to comply with the rule, manufacturers have realized that the problem to be solved is multi-faceted and interconnected. It’s like the ancient Greek myth of Pandora opening the box releasing the not-so-pleasant things into the world. Although kinder to the industry than originally anticipated, the FDA’s UDI ruling is more complicated than just a labeling change, making implementation a challenge. Continue reading

Are You Ready for UDI? Six Questions to Ask Yourself

Are You Ready for UDI? Six Questions to Ask YourselfThe final ruling for UDI regulations in medical device has been released! In September 2014, all companies must be compliant. Don't wait to mobilize your UDI efforts. The clock is already ticking…are you ready? Continue reading