Full Description

Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data

Product Details

Published: 06/05/2016 ISBN(s): 9781570206122 ANSI: ANSI Approved Number of Pages: 84 File Size: 1 file , 4.8 MB