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Welcome! 0 hr 1 min
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Session Recording 0 hr 45 min
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Conclusion 0 hr 1 min
Pre-Market vs. Post Market Risk: What are the similarities and differences?
A session by Mike Drues Ph.D., President at Vascular Sciences
- What does risk mean pre-market vs. post-market?
- How do we estimate risk before we have a device or history of use?
- How does risk differ for a 510k vs. a de novo?
- How do we address risk in a pre-sub?
- How do we handle risk while our device is on the market?
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