AAMI TIR38:2019

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Medical device safety assurance case guidance

This technical information report provides guidance on how to complete an Assurance Case Report in order to comply with the new additional FDA pre-market requirements for infusion pumps. It includes a detailed but strictly hypothetical example from the medical device domain.

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Association for the Advancement of Medical Instrumentation [aami]

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Medical device safety assurance case guidance

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AAMI TIR38:2019

Medical device safety assurance case guidance

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

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