Title :
Integration of software reliability engineering, risk management and safety assurance case
Abstract :
A collection of slides from the author´s conference presentation is given. The following topics are discussed: GessNet; medical device risk management; safety assurance case development; FDA submissions; FDA inspections; ISO 13485 quality system audits; software reliability engineering; product quality; software quality; software defects; and medical device software.
Keywords :
ISO standards; auditing; medical computing; risk management; security of data; software reliability; FDA inspections; FDA submissions; GessNet; ISO 13485 quality system audit; medical device risk management; medical device software; product quality; safety assurance case development; software defect; software quality; software reliability engineering; Computers; Electronic mail; ISO standards; Risk management; Safety; Software; Software reliability;
Conference_Titel :
Software Reliability Engineering Workshops (ISSREW), 2013 IEEE International Symposium on
Conference_Location :
Pasadena, CA
DOI :
10.1109/ISSREW.2013.6688898
