AAMI TIR38:2019
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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.
Product Details
- Published:
- 01/25/2019
- Number of Pages:
- 51
- File Size:
- 1 file , 1.4 MB