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.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode: