QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg

The lead author of the US Food and Drug Administration’s Quality System Regulation predicts that device makers won’t need as much time as the agency to adapt to a new QSR that’s harmonized with international quality systems standard ISO 13485:2016.

“Under the assumption that FDA is successful in their intended purpose of further harmonizing [the Quality System Regulation] to match 13485, then industry should need little time to transition,” said...