AssurX Blog
Straight talk for regulated industries.
CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate
The Center for Devices and Radiological Health or CDRH will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 [...]
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. AdvaMed’s Comments on FDA UDI Impl [...]
Interpreting the FDA View of Medical Device Design Controls
Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc. Some of the shortest descriptions in the FDA CFR 21 Part 820 Quality System regulation a [...]
