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    • SaMD Compliance & Software Documentation
    • External PRRC & QMR Services
    • In-Country Representation for Medical Devices & SaMD
    • Micro Consulting for MedTech & SaMD Compliance
  • Training
    • Workshops & Inhouse Training
    • Regulatory Accelerator Programs
    • Startup Office Hours
    • Our Courses
  • About us
  • Resources
  • Contact us
  • FAQs

Monthly Archives: June 2023

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Validation vs. Verification

Validation vs Verification: What’s the Difference in Medical Software?

Regulatory AffairsBy Anne ArndtJune 1, 2023Leave a comment

The difference between validation and verification, especially in the context of Software as a Medical Device (SaMD), can be quite nuanced and often confuses many. This is largely due to the fact that various regulatory bodies like the FDA, and international standards such as IEC 62304 and IEC 82304-1, may use these terms in slightly…

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