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Human Factors & Risk Management: What's Needed & Why?

Global Medical Device Podcast powered by Greenlight Guru

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What Are You Looking for From a Human Factor?

FDA moved the 6236 safety standard to focus on usual need risk and then take all of that other information, which was good. "I'm trying to frame all of the data through the lens of how does this help me understand if this supports safe and effective use," he said. He says there were a few things he noticed going from industry into into CDRH specifically. 'It felt like I had a blinders on'

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