AssurX Blog
Straight talk for regulated industries.
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 [...]
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 [...]
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, to put it mildly, concerning label enforcement. With that slight [...]
Part II: Next Practices for Selecting an Enterprise Quality System
Note: In part one, we looked at how to approach the selection process, assess vendor capabilities, and find the right philosophical "match" for your particular organization. In part tw [...]
