AAMI TIR50:2014(R2017)
Current
The latest, up-to-date edition.
Post-market surveillance of use error management
Hardcopy , PDF
English
06-12-2017
The guidelines described in this technical information report (TIR) are not separate from or in opposition to the existing U.S. Food and Drug Administration’s (FDA’s) and other regulatory bodies' reporting protocols for product failure or adverse events (concerning morbidities or mortalities), which already have standardized protocols.
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.