How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) development processes?
Today’s guest is Cathy Wilburn, Director of Quality Assurance and Compliance for The RND Group, a medical device software development company that helps clients write software, submission readiness, and compliance. Cathy joins Jon Speer to clarify the confusing parts of IEC 62304 and helps listeners understand how they can leverage this standard to improve development processes.
“(IEC 62304) defines software lifecycle processes for medical device software. It’s recognized by the FDA as a consensus standard.”
“A consensus standard is something that’s developed by private sector. It’s not developed by the FDA, so it’s not a regulation.”
“It gives you the freedom to introduce it into your software development organization that you already have established.”
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