政府应该监管医疗软件吗?

Fifth Annual Conference on Computer Assurance, Systems Integrity, Software Safety and Process Security. Pub Date : 1900-01-01 DOI:10.1109/CMPASS.1990.175420

R. Britain, J. Paul

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引用次数: 0

摘要

美国食品和药物管理局在规范计算机控制的医疗设备的软件的作用是解决。FDA软件审查指南草案侧重于规范软件方面而不是系统方面，讨论了从事软件开发的制造商或个人的许可以及医疗软件开发监管对小型医疗制造商和初创企业的影响

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Should government regulate medical software?

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.<>

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Fifth Annual Conference on Computer Assurance, Systems Integrity, Software Safety and Process Security.

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