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AAMI TIR38:2019

Medical device safety assurance case report guidance

Pages: 51
Publication date: 2019-01-25
Price: 243 vnd

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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.
Document identifier
AAMI TIR38:2019
Title
Medical device safety assurance case report guidance
AAMI Category
Diagnostic and Monitoring, General and Miscellaneous
Publication date
2019-01-25
Status
Effective
International Relationship
Cross references
Latest version
AAMI TIR38:2019
Medical device safety assurance case report guidance
Document identifier AAMI TIR38:2019
Publication date 2019-01-25
Classification
Status Effective
*
History of version
AAMI TIR38:2019 * AAMI TIR38:2014
Keywords
Classification
Pages
51
Price 243 vnd