FDAnews Management Report Available

http://www.onlinetmd.com/fda-management-report-040312.aspx

Despite years of harmonization talks, the EU and United States still follow very different marketing approval processes for medical devices. In addition, when the EU's MDD went into effect in 2010, those differences are more pronounced.
Failing to know the differences could critically handicap your time to market and ability to operate efficiently.
Failing to comply with those differences could shut you out of EU markets completely.
EU and FDA regulators continue to apply different sets of requirements for medical device market approval, despite longstanding attempts at harmonization.
Do you understand how CE marking, PMA approval, and 510(k) clearance processes differ? Are you prepared for the impact of recent major revisions to the EU Medical Devices Directives?
Here is how to make sure you're fully informed – and in compliance.