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2014 Hot Spots: Top 4 Device Quality & Regulatory Topics

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.

If the chief concern of medical device manufacturers in 2014 could be summed up in one (albeit tweaked) political bon mot, it would be, "It's the inspections, stupid."

Information about facility audits piqued the interest of most "Silver Sheet" online readers during the past year. ("The...

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