AAMI TIR38:2014 (AAMI TIR 38:2014)

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Medical device safety assurance case report guidance

This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to assure and document the safety of a medical device’s design.

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Association for the Advancement of Medical Instrumentation [aami]

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Medical device safety assurance case report guidance

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AAMI TIR38:2014 (AAMI TIR 38:2014)

Medical device safety assurance case report guidance

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

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