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: 08/03/2016 ISBN(s): 1570206120 ANSI: ANSI Approved Number of Pages: 84File Size: 1 file , 4.6 MB