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AAMI TIR38:2014

Medical device safety assurance case report guidance

Pages: 55
Publication date: 2014-12-23
Price: 236 vnd

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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.
Document identifier
AAMI TIR38:2014
Title
Medical device safety assurance case report guidance
AAMI Category
Diagnostic and Monitoring, General and Miscellaneous
Publication date
2014-12-23
Status
Ineffective
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 * AAMI TIR38:2019 * AAMI TIR38:2014
Keywords
Classification
Pages
55
Price 236 vnd

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