A plan by the US Food and Drug Administration to harmonize its Quality System Regulation with ISO 13485 is rolling along despite one FDA official's recent claim that only a "limited number of staff" are acquainted with the international standard.
In a blog post exactly one year ago, then-FDA Commissioner Scott Gottlieb announced that the two documents would be merged, and the agency soon after added the QSR redo...
Device-makers use ISO 13485 to ensure quality systems compliance with regulators in a variety of countries, including Canada, Japan, Australia and the 28 member states of the European Union.