Using Dynamic Software Analysis to Support Medical Device Approval

By 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. Read More

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