EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs FDA Quality Management System Regulation (QMSR)
What is the difference between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) is a other framework applying in the European Union, with 26 controls across 7 domains. FDA Quality Management System Regulation (QMSR) is a quality management framework applying in the United States, with 13 controls across 7 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)26 controls
FDA Quality Management System Regulation (QMSR)13 controls
Questions people ask about EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)
What is the difference between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)?
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 26 controls while FDA Quality Management System Regulation (QMSR) has 13 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR)?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR) so you can identify shared requirements and avoid duplicate effort.
How do EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR) controls map to each other?
Our platform maps controls between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR) at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, EU In Vitro Diagnostic Medical Devices Regulation (IVDR) or FDA Quality Management System Regulation (QMSR)?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
EU In Vitro Diagnostic Medical Devices Regulation (IVDR) vs GDPR3 shared controlsFDA Quality Management System Regulation (QMSR) vs SWIFT CSCF5 shared controlsFDA Quality Management System Regulation (QMSR) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements5 shared controlsFDA Quality Management System Regulation (QMSR) vs BRCGS Global Standard for Food Safety Issue 95 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and FDA Quality Management System Regulation (QMSR) on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.