The not-so-practical “practical guide” to ISO 13485:2016 (Part 3)

How do you apply the Practical Guide for the implementation of a “risk-based approach?” I'm glad you asked....

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The not-so-practical “practical guide” to ISO 13485:2016 (Part 2)

Michelle explores how the Practical Guide defines “risk-based approach,” the varying terminology, and the...

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The not-so-practical “practical guide” to ISO 13485:2016 (Part 1)

Now, you tell me: What part of a 214-page guide sounds "practical" to you? Yeah, so I'm distilling down the "Practical G...

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