QMSR / ISO 13485 vs IEC 62304
What's actually different between the QMS regulations medical device manufacturers must follow — clause-by-clause comparison from the Kelsey Quality crosswalk library.
kelseyqms.com/crosswalk/compare/qmsr-vs-iec-62304
vs
Explore individual standards
49
34
37
4
What's actually different
StatusCurrent (effective Feb 2, 2026)Current — IEC 62304:2006+AMD1:2015
Effective periodFeb 2026 – present2006 (amended 2015) – present
Total requirements4926
Risk integrationRequired (links to ISO 14971 throughout design)Required — software safety class drives lifecycle rigor
Plan maintenanceRequired throughout developmentUpdated at each phase gate per development plan
Document approvalExplicit approval signatures requiredFormal checklist approval before each lifecycle phase
Most common gapRisk management file weak or unlinked to designSafety class under-assigned; traceability matrix incomplete
Audit focusRisk file integrity and design-control linkageSafety classification rationale and requirements traceability
What's shared, what's distinct
34
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Risk Management
- • Corrective and Preventive Action (CAPA)
- • Document Control
- + 28 more
37
- • Design and Development Review
- • Management Review
- • Complaint Handling
- • Medical Device File
- • Supplier Management
- • Process Validation
- + 31 more
4
- • Legacy Software Risk Management Activities
- • Legacy Software Gap Analysis
- • Legacy Software Gap Closure Activities
- • Legacy Software Rationale for Continued Use