IEC 62304:2015 Medical Device Software Lifecycle Processes vs SOC 2
What is the difference between IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2?
IEC 62304:2015 Medical Device Software Lifecycle Processes is a other framework applying in International, with 33 controls across 17 domains. SOC 2 is a other framework applying in the United States, with 61 controls across 5 domains. Both govern the same subject, so their requirements overlap; the mapping below shows which controls carry across and which are asked for by only one of them.
IEC 62304:2015 Medical Device Software Lifecycle Processes33 controls
SOC 261 controls
Questions people ask about IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2
What is the difference between IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls while SOC 2 has 61 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2 so you can identify shared requirements and avoid duplicate effort.
How do IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2 controls map to each other?
Our platform maps controls between IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2 at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, IEC 62304:2015 Medical Device Software Lifecycle Processes or SOC 2?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
See all control mappings with interactive gap analysis
Explore the complete mapping between IEC 62304:2015 Medical Device Software Lifecycle Processes and SOC 2 on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.