QA/RA Consulting, Auditing & Training
Stop Calling It Risk Based. Start Proving It. Most companies say that their quality management systems are risk based. FDA will ask you to prove it. Under the FDA’s Quality Management System Regulation (QMSR), that distinction is getting harder to ignore. As inspections evolve, the question isn’t just whether risk is documented. Instead, it’s whether […]
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Why FDA Inspections Feel Different Now: Part II – SaMD, IEC 62304, and AI Enabled Devices In Part I, we explored why FDA inspections feel different under QMSR: inspectors are following risk, connecting information across the product lifecycle, and evaluating how quality systems actually function in practice. For software-driven products, those same shifts are even more […]
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Why FDA Inspections Feel Different Under QMSR: Part I Are you anticipating an FDA inspection in the near future? Things have changed under the new QMSR. In this blog post we discuss what you can now expect when FDA inspectors come calling. 1. The rules didn’t radically change but the lens FDA uses absolutely did […]
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QMSR Is Taking the Spotlight, But MDSAP Still Deserves Attention Why does MDSAP still deserve attention? Because “we’ve aligned to QMSR” and “we’re ready for MDSAP” are not the same thing. At some point in a lot of QMSR transition efforts, things start to feel pretty good. Processes have been updated. Risk-based thinking is getting […]
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QMSR: Why ├óΓé¼┼ôDoing├óΓé¼┬¥ Risk Management Isn├óΓé¼Γäót Enough Anymore FDA├óΓé¼Γäós transition to the Quality Management System Regulation (QMSR) isn’t just a paperwork exercise. While the alignment with ISO 13485 is old news, the real concern for manufacturers isn’t in the logic of risk ├óΓé¼ΓÇ£ it├óΓé¼Γäós in the evidence. Simply performing risk management activities is no longer […]
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Key Regulatory References for the FDA Medical Device Inspection Compliance Program IntroductionFDA has released the Inspection of Medical Device Manufacturers Compliance Program 7382.850, effective February 2, 2026, formally replacing the long-standing Quality System Inspection Technique (QSIT). That alone is a big deal. Combined with the rollout of the Quality Management System Regulation (QMSR), it signals […]
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