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AAMI TIR38-2019/(R)2026 PDF
AAMI TIR38-2019/(R)2026 PDF
AAMI TIR38-2019/(R)2026 PDF
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AAMI TIR38-2019/(R)2026 PDF

Medical device safety assurance case report guidance

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$171.50 $343.00 -50%
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Product Code: AAMI TIR38-2019/(R)2026
Stock In Stock
Published: 01/25/2019
Number of Pages: 51
File Size: 1 file, 1 Byte

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Product Description

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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AAMI TIR38-2019/(R)2026 PDF

AAMI TIR38-2019/(R)2026 PDF

$171.50 $343.00