AAMI TIR38:2019

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. This TIR provides information useful to creating and maintaining safety assurance cases for medical devices, including drug delivery combination products. It does this in the context of ANSI/AAMI/ISO 14971 and ISO/IEC 15026-2. A safety assurance case serves as a detailed risk management report that, as part of the risk management file, should be maintained according to the requirements of ANSI/AAMI/ISO 14971. There is additional discussion about the relationship between risk management and safety assurance cases in clause 7. No annex