DocumentCode
2815564
Title
Should government regulate medical software?
Author
Britain, R.G. ; Paul, J.H.
Author_Institution
Nat. Electr. Manuf. Assoc., Washington, DC, USA
fYear
1990
fDate
25-28 June 1990
Firstpage
189
Lastpage
191
Abstract
The role of the US Food and Drug Administration in regulating the software of computer-controlled medical devices is addressed. The FDA draft software review guide´s focus on regulating software aspects rather than system aspects, the licensing of manufacturers or individuals engaged in the software development and the effects of regulation of medical software development on small medical manufacturers and start-ups are discussed.<>
Keywords
contracts; government policies; medical computing; quality control; software reliability; systems analysis; FDA draft software review; computer-controlled medical devices; licensing; manufacturers; medical software development; small medical manufacturers; software aspects; system aspects; Government; Hazards; Licenses; Manufacturing; Product development; Programming; Quality assurance; Safety devices; Software quality; Software safety;
fLanguage
English
Publisher
ieee
Conference_Titel
Computer Assurance, 1990. COMPASS '90, Systems Integrity, Software Safety and Process Security., Proceedings of the Fifth Annual Conference on
Conference_Location
Gaithersburg, MD, USA
Type
conf
DOI
10.1109/CMPASS.1990.175420
Filename
175420
Link To Document