2014 Hot Spots: Top 4 Device Quality & Regulatory Topics
This article was originally published in The Gray Sheet
Big changes are afoot for inspections, and device stakeholders kept a sharp eye on those issues in 2014, according to readership data from "The Silver Sheet." From a CDRH/ORA plan to create a specialized unit of device-focused field investigators, to IMDRF's mostly untested internationally harmonized single-audit approach, readers (and podcast listeners) couldn't get enough news and tips about inspection activities. A recap of in-depth "Silver Sheet" coverage from the year, including updated expert commentary, follows.