AAMI TIR38:2014

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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. Includes a detailed but strictly hypothetical example from the medical device domain.

Product Details

Edition:

1st

Published:

12/23/2014

Number of Pages:

55

File Size:

1 file , 1.7 MB