DocumentCode
2178239
Title
FMEA for rework reduction in medical device software-experience
Author
Deora, S.
Author_Institution
Philips Electron. India Ltd., Bangalore, India
fYear
2013
fDate
28-31 Jan. 2013
Firstpage
1
Lastpage
4
Abstract
Safety and Effectiveness of the product is crucial part of medical devices as it deals with human lives. In the case of medical device software it is important to establish processes, activities and tasks which assure that the software has been developed in a manner that is likely to produce highly reliable and safe products. It is proven that most of the software failures are design failures and hence the quality and reliability has to be built into the software design for the medical device software.
Keywords
biomedical equipment; failure analysis; medical computing; safety; safety-critical software; FMEA; effectiveness; failure mode and effect analysis; medical device software; quality; reliability; safety; Reliability engineering; Risk management; Robustness; Safety; Software; CONQ (Rework Factor); CTQ; FMEA;
fLanguage
English
Publisher
ieee
Conference_Titel
Reliability and Maintainability Symposium (RAMS), 2013 Proceedings - Annual
Conference_Location
Orlando, FL
ISSN
0149-144X
Print_ISBN
978-1-4673-4709-9
Type
conf
DOI
10.1109/RAMS.2013.6517685
Filename
6517685
Link To Document