QMSR Transition

Navigating the QMSR Transition

The FDA’s Quality Management System Regulation (21 CFR 820) aligns U.S. medical-device quality requirements with ISO 13485:2016 and increases regulatory scrutiny on post-market processes, supplier controls, and documentation integrity.

Organizations without compliant systems face heightened enforcement risk, delayed commercialization, and increased audit exposure

Clearway's Compliance Approach

Gap Analysis & Risk Assessment

  • System-level review of ISO 13485 and QMSR alignment
  • Post-market surveillance and supplier control evaluation
  • Regulatory risk mapping and prioritization
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Rapid QMS Modernization

  • Document architecture and control system implementation
  • CAPA and complaint handling workflow alignment
  • Internal audit program deployment

Inspection Readiness

  • Mock FDA inspections
  • Executive and board-level compliance briefings
  • Ongoing audit preparation
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