ISO 13485 vs MDS2 (Medical Device)
What is the difference between ISO 13485 and MDS2 (Medical Device)?
ISO 13485 is a other framework applying in International, with 29 controls across 11 domains. MDS2 (Medical Device) is a other framework applying in the United States, with 8 controls across 8 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.
ISO 1348529 controls
MDS2 (Medical Device)8 controls
Questions people ask about ISO 13485 and MDS2 (Medical Device)
What is the difference between ISO 13485 and MDS2 (Medical Device)?
ISO 13485 has 29 controls while MDS2 (Medical Device) has 8 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 ISO 13485 and MDS2 (Medical Device)?
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 ISO 13485 and MDS2 (Medical Device) so you can identify shared requirements and avoid duplicate effort.
How do ISO 13485 and MDS2 (Medical Device) controls map to each other?
Our platform maps controls between ISO 13485 and MDS2 (Medical Device) 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, ISO 13485 or MDS2 (Medical Device)?
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.
ISO 13485 vs NIST SP 800-6613 shared controlsISO 13485 vs MARS-E13 shared controlsISO 13485 vs ISO 2779913 shared controlsMDS2 (Medical Device) vs OWASP DevSecOps Maturity Model (DSOMM)5 shared controlsMDS2 (Medical Device) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements5 shared controlsMDS2 (Medical Device) vs FTC GLBA Safeguards Rule (16 CFR Part 314)5 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between ISO 13485 and MDS2 (Medical Device) on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.