AAMI TIR38 – Medical device safety assurance case report 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.
Product Details
- Published:
- 01/25/2019
- Number of Pages:
- 51
- File Size:
- 1 file 1.4 MB
- Note:
- This product is unavailable in Belarus Russia Ukraine
