IEC 62304:2015 Medical Device Software Lifecycle Processes vs COBIT 2019

IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls while COBIT 2019 has 40 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.

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 COBIT 2019 so you can identify shared requirements and avoid duplicate effort.

Our platform maps controls between IEC 62304:2015 Medical Device Software Lifecycle Processes and COBIT 2019 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.

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.