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AAMI TIR105:2020

Risk management guidance for combination products
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AAMI TIR105:2020

Risk management guidance for combination products

PUBLISH DATE 2020
AAMI TIR105:2020
This technical information report provides recommendations and processes to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR105
Publication Date Sept. 28, 2020
Language en - English
Page Count 41
Revision Level
Supercedes
Committee
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