FDA 21 CFR Part 11 vs ISO 13485
What is the difference between FDA 21 CFR Part 11 and ISO 13485?
FDA 21 CFR Part 11 is a compliance framework applying in the United States, with 13 controls across 7 domains. ISO 13485 is a compliance framework applying in International, with 67 controls across 5 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.
FDA 21 CFR Part 1113 controls
ISO 1348567 controls
Questions people ask about FDA 21 CFR Part 11 and ISO 13485
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 67 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.
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.
FDA 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems9 shared controlsFDA 21 CFR Part 11 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)7 shared controlsFDA 21 CFR Part 11 vs US Consumer Product Safety Commission (CPSC) - Connected Product Safety6 shared controlsISO 13485 vs NIST SP 800-6613 shared controlsISO 13485 vs MDS2 (Medical Device)13 shared controlsISO 13485 vs MARS-E13 shared controls
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.
Written and maintained by Gerard Blokdyk, The Art of Service.