FDA 21 CFR Part 11 vs ISO 13485
Compare FDA 21 CFR Part 11 and ISO 13485 across controls, requirements, and compliance scope. Use our compliance platform to see the full control-to-control mapping between these two frameworks.
FDA 21 CFR Part 1113 controls
ISO 1348529 controls
Frequently Asked Questions
What is the difference between FDA 21 CFR Part 11 and ISO 13485?
FDA 21 CFR Part 11 has 13 controls while ISO 13485 has 29 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 FDA 21 CFR Part 11 and ISO 13485?
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 FDA 21 CFR Part 11 and ISO 13485 so you can identify shared requirements and avoid duplicate effort.
How do FDA 21 CFR Part 11 and ISO 13485 controls map to each other?
Our platform maps controls between FDA 21 CFR Part 11 and ISO 13485 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, FDA 21 CFR Part 11 or ISO 13485?
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.
Learn More About Each Framework
See all control mappings with interactive gap analysis
Explore the complete mapping between FDA 21 CFR Part 11 and ISO 13485 on our compliance platform.