Regulatory Standards Crosswalk
Kelsey scans your quality documents against the standards that matter. Every requirement mapped, every gap identified.
MOST-ASKED COMPARISON
QMSR vs Part 820: what's actually 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 foundation of FDA medical device quality systems. 37 requirements covering design controls, CAPA, supplier management, and more.
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 requirements ensuring medical devices are safe and effective for intended users.
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 →COMPARE ANY TWO STANDARDS
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