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The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite

 
• By Shawn M. Schmitt

Kim Trautman, who authored the Quality System Regulation in the 1990s, says US FDA officials tasked with retooling the QSR will have to consider an array of other device-related rules that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by manufacturers.

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When US FDA begins the long-overdue revision of its Quality System Regulation, it won't be retooling the decades-old rule in a silo. Instead, agency officials tasked with the QSR redo will have to consider satellite device regulations that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by device-makers.

That's according to former FDAer Kim Trautman, author of the QSR in the 1990s, who is now executive VP of...

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