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Device Week, Aug. 22, 2018 – Quality System Regulation + ISO 13485 = ?

Executive Summary

On this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485.


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The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite
QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like
US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485





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