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Using Dynamic Software Analysis to Support Medical Device Approval

Authored on: Oct 1, 2012 by Chris Ault, Mark Pitchford

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Two key challenges facing medical device software manufacturer are a) demonstrating safety and b) obtaining approval by regulatory agencies. This paper looks at how dynamic code analysis can support demonstrations of compliance with safety requirements, and key capabilities to look for in dynamic analysis tools. It concluded with tables mapping development activities with requirements in the IEC 62304 standard, and a short description of important OS characteristics.

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