AssurX Blog
Straight talk for regulated industries.
1301, 2014
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 [...]
701, 2014
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 [...]
1202, 2013
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 [...]
