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The importance of medical device testing need not be stressed enough for it directly impinges on the health of a person. In case there is a software glitch in a system that deals with critical care the result can lead to an unfortunate case or even loss of life as well. Given the possibility of such dire outcomes, medical device testing needs to be conducted under stringent quality guidelines only.

The increased use of medical devices in the diagnosis and treatment of diseases has raised the issue of safety and reliability of such devices. To ensure that these devices meet international quality standards, medical device software testing has been adopted