Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

AAMI TIR38:2019

Medical device safety assurance case guidance

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.


Content Provider
Association for the Advancement of Medical Instrumentation [AAMI]


Others Also Bought

AAMI TIR97:2019
Principles for medical device security - Postmarket risk management for device manufacturers
AAMI TIR101:2021
Fluid delivery performance testing for infusion pumps
AAMI TIR32:2004 (R2016)
Medical device software risk management
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS