Using Dynamic Software Analysis to Support Medical Device Approval

February 20, 2014 // By Mark Pitchford, Chris Ault, QNX Software Systems

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Two key challenges facing medical device software manufacurer are a) demonstrating safety and b) obtaining approval by regulatory agencies. In this paper we look at how dynamic code analysis can support demonstrations of compliance with safety requirements, and key capabilities to look for in dynamic analysis tools. We conclude with tables mapping development activities with requirements in the IEC 62304 standard, and a short description of important OS characteristics.
QNX, LDRA, IEC 62304, medical software, OS, RTOS, validation, FDA, MDD, MHRA, premarket approval, 501(k), IEC 61508, dynamic analysis, static analysis, medical device, QNX Neutrino RTOS, QNX Neutrino RTOS Safe Kernel, safe kernel, RTOS, OS, real-time oper