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SysML Activity Models for Applying ISO 14971 Medical Device Risk and Safety Management Across the System Lifecycle
Author(s) -
Malins Robert J.,
Stein Jack,
Thukral Ajay,
Waterplas Christophe
Publication year - 2015
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2015.00077.x
Subject(s) - systems modeling language , computer science , systems engineering , process (computing) , product life cycle management , safety assurance , unified modeling language , risk analysis (engineering) , process management , software engineering , reliability engineering , engineering , medicine , mechanical engineering , software , programming language , operating system
The INCOSE Biomedical‐Healthcare Model‐Based Systems Engineering (MBSE) Challenge Team has been exploring applications of MBSE techniques to medical device development. Because patient and user safety is paramount in medical devices, the team has focused on using MBSE techniques to address safety topics. This paper uses MBSE methods to address the processes of analyzing safety and incorporating risk control at each step of the development portion of the system life cycle in order to achieve “built in” safety. SysML activity models are presented that link the steps of ISO 14971 to the system development technical processes of ISO 15288. In addition, the models show how the analysis results of ISO 14971 can be used to develop a system safety assurance case. The activity models explicitly show the iterative and recursive approach to applying risk management at each stage of system development and address the ISO 13485 requirement for process integration.