AssurX Blog
Straight talk for regulated industries.
Are Energy and Utility Companies Ready for Risk Based Compliance?
Part 1: How the NERC Registered Entities are Preparing As we enter into the New Year, many NERC Registered Entities are focused on their game plan to prepare and implement the “ERO Ent [...]
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fiscal Year 2014 - In our last FDA FastStats series of the year, we look back at all FDA 483 Inspectional Ob [...]
FDA Update on UDI Implementation for Registered Medical Device Establishments
In case you missed it, the FDA issued this update on UDI yesterday: Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III dev [...]
Got Safe Beef? New Report Suggests the US Doesn’t
FSMA: Got Safe Beef? New Report Suggests the US Doesn't: The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Bas [...]
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies: In our latest infographic analysis, today's post highlights medical device warning l [...]
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approach the end of 2014, we will take a look back at FDA's stats on various topics sourced from their Case fo [...]