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

Global Medical Device Podcast powered by Greenlight Guru

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The Heart of the Problem Is the Seat of the Solution

Risk assessment is more of an FDA coin term it's very similar to like a use of me so it's just taking and identifying us errors, and then you know what could result from that use here. But as you're walking through that tool and like I just mentioned, staying out of solution space. It's really good to walk through it step wise first identify all of the tasks don't think any further about them just identify them,. And then think about what can go wrong at each step.

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