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Life Sciences
The Six C’s of Complaints Management Best Practices for Life Sciences
Jeff Mazik, Vice President, Life Science Solutions, AssurX Companies in the Pharmaceutical, Medical Device, and Biotec [...]
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 [...]
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 mayb [...]
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) addre [...]
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 [...]
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 des [...]
