Ale Fest returns to Tremont in July. Early bird tickets are available right now!

This is a past event.

Device Changes, FDA Changes, and the 510(k)-2019 

When: Wed., March 20, 10-11 a.m. 2019
Phone: 800-447-9407
Price: 150.00
Overview: Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based? Areas Covered in the Session: Is the process "risk based"? K-97-1 and the FDA's "Decision Tree" Documenting the process / rationale Resolving a "wrong decision"


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