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Section about intended use

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Guest user Created:   Mar 25, 2021 Last commented:   Mar 28, 2021

Section about intended use

IN the toolkit we have purchased, I cant seam to find a section about intended use. Which document caters for that? What ive found so far is just technical file, but not to the extent I thought was required.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 28, 2021

Intended use is covered in the Technical file Integrated and both in the Clinical evaluation plan and Clinical evaluation report.

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Mar 25, 2021

Mar 28, 2021