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ROI CalculatorQSR to QMSR is a structural shift in how medical device quality systems are designed, evaluated, and enforced. Understanding what has changed and why it matters is essential for manufacturers preparing for inspections, global alignment, and long-term compliance readiness.
Every FDA inspection now follows QMSR. Systems built for QSR are already being evaluated as outdated.
Validation gaps or missing records now trigger 483s, funding delays, and market setbacks.
Your QMS needs to support audits, growth, and product launches at the same time.
Terminology shift: Purchasing Controls → Control of External Providers, Supplier Management.
Risk management: Risk drives decisions across design, suppliers, changes, and post-market.
Record access: FDA will ask manufacturers for evidence across design controls, production, supplier audits, management reviews, impact analysis, and audit trails.
The FDA QMSR framework is officially live. Onboard Easy
Discover how closed-loop quality enables audit readiness, continuous compliance, and operational control under FDA’s new framework.
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Rebuilding your quality system for QMSR is costly, slow, and risky. Qualityze is a purpose-built platform that eliminates rework with pre-aligned controls, standardized terminology, and workflows already operating in regulated environments.
Comply with pre-defined templates and fields in QMSR language. Standardize forms and workflows for your people, your processes.
Link your audits with relevant supplier, CAPA, and training records. Better traceability and visibility from day one.
Easy to navigate and configure dashboard. Focus on what really matters – QMSR and ISO 13485. AI-enabled for predictive insights.
