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  • Services
    • Regulatory Consulting Services
    • SaMD Consulting Services
    • External PRRC
    • External QMR
    • In-Country Representation
    • Regulatory Monitoring
    • Micro Consulting
  • Training
    • Medical Device University
    • Courses
  • Startups
    • Regulatory Accelerator
    • Startup Office Hours
    • Free Resources
  • News
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9 August 2024


qsr qmsr iso

Download Our Comprehensive Comparison of QSR, QMSR and ISO 13485 Requirements

By Anne Arndt9 August 2024Leave a comment

The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) signifies a pivotal shift for medical device manufacturers. As of February 2, 2024,…

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