AssurX Blog
Straight talk for regulated industries.
FERC Order to Impose Stricter Physical Security Standards on Electric Utilities
On March 7th, FERC released a new order (Docket No. RD14-6-000) directing the North American Electric Reliability Corporation (NERC) to develop new reliability standards for the NERC r [...]
CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate
Tamar June, President & CEO, AssurX, Inc. The Center for Devices and Radiological Health or CDRH will focus on encouraging medical device innovation and speeding clinical trials [...]
NERC and Industry Move in the Right Direction for Greater Reliability
There is a different feel out there in the NERC world, the Electric Reliability Organization (ERO) and the registered entities are working together more than ever since the mandatory i [...]
Medical Device Makers Urged to Play Nicer by Sharing Data
You shouldn't need Barney the giant purple dinosaur to remind you of the playground mantra "sharing is caring," but maybe the medical device industry needs to do some quick Netflix str [...]
Analysis: No Need For State of the Union Analysis
Those of us in and around Washington D.C. like to tell folks leading up to a president's State of the Union (SOTU) address that the speeches rarely matter and are generally forgotten w [...]
Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative
Let's start with what most everyone agrees on: The Unique Device Identification or UDI program is a swell idea. It gets a little trickier after that. In extensive comments, the Advance [...]
