Regulatory Standards Crosswalk
Kelsey scans your quality documents against the standards that apply to your device, mapping each requirement and showing you where the gaps are.
MOST-ASKED COMPARISON
QMSR vs Part 820: what's changing
The new FDA Quality Management System Regulation replaces 21 CFR Part 820 effective February 2, 2026. See how your existing quality system maps to the new requirements.
QMSR / ISO 13485
49 requirementsThe FDA's quality system regulation for medical devices, now harmonized with ISO 13485. Covers design controls, CAPA, supplier management, and document control.
View crosswalk →IEC 62304
26 requirementsSoftware lifecycle process requirements for medical device software. Covers safety classification, development planning, testing, and maintenance.
View crosswalk →IEC 62366
14 requirementsUsability engineering for medical device user interfaces — use specification, formative evaluation, and summative evaluation.
View crosswalk →ISO 14971
9 requirementsRisk management process requirements for medical devices. Hazard identification, risk evaluation, and control through the product lifecycle.
View crosswalk →IEC 81001-5-1
46 requirementsCybersecurity lifecycle requirements for health software. Threat modeling, secure development, vulnerability management.
View crosswalk →FDA Cybersecurity
23 requirementsFDA premarket cybersecurity requirements including SBOM, penetration testing, and coordinated vulnerability disclosure.
View crosswalk →CROSS-STANDARD VIEW
Browse by discipline
Quality management, risk, software lifecycle, cybersecurity, and usability engineering requirements gathered from all standards in one place.
View requirements by discipline →COMPARE ANY TWO STANDARDS
Browse all 15 comparisons
Every pairing in the crosswalk library — pick any two standards to see what's shared, what's new, and what's retired.
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