
Risk-Based Approach as Clear as Mud
January 16, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.
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