QMSR / ISO 13485 vs FDA Postmarket
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-postmarket
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Explore individual standards
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What's actually different
Status——
Effective period——
Total requirements4918
Risk integration——
Plan maintenance——
Document approval——
Most common gap——
Audit focus——
What's shared, what's distinct
8
- • Complaint Handling
- • Regulatory Reporting
- • MDR Reporting Requirements — General Obligations
- • Written MDR Procedures
- • MDR Event Files and Records Retention
- • Manufacturer MDR Reporting — Adverse Event Investigation and Submission
- + 2 more
47
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- + 41 more
12
- • Reports of Corrections and Removals
- • Records of Corrections and Removals Not Required to Be Reported
- • FDA Access to Corrections and Removals Records
- • Cease Distribution and Notification Order — Compliance Obligations
- • Mandatory Recall Order — Strategy and Status Reporting
- • Postmarket Surveillance Order — Applicability and Plan Submission
- + 6 more