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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 [...]
FDA’s 2014 Promises Increased International Operations, Label Enforcement
Given the fact that the FDA probably doesn't know what it plans to do in 2014, predicting their actions is challenging, [...]
Part II: Next Practices for Selecting an Enterprise Quality System
Note: In part one, we looked at how to approach the selection process. We assessed vendor capabilities and found the rig [...]
