The Complaint Nobody Called a Complaint: Why Medical Device Companies Miss Early Warning Signals
The Complaint Nobody Called a Complaint: Why Medical Device Companies Miss Early Warning Signals Most complaint-handling failures do not begin when an investigation is missed. Instead, they start earlier, at the moment when no one realizes they are looking at a potential complaint. For example, a customer mentions an unusual product issue during a support […]
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Stop Calling It Risk Based. Start Proving It.
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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QMSR: Why “Doing” Risk Management Isn’t Enough Anymore
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
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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Understanding FDA’s 2025 Draft Guidance on AI-Enabled Medical Devices
Understanding FDA├óΓé¼Γäós 2025 Draft Guidance on AI-Enabled Medical Devices Key Life-Cycle Management and Submission Recommendations for Manufacturers The rapid advancement of artificial intelligence (AI) in healthcare has led to a surge in AI-enabled medical devices, transforming diagnostics, treatment, and patient monitoring. Recognizing the complexities and unique risks associated with these technologies, the US Food and […]
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Less Than A Year to Go! FDA New Quality Management System Regulation (QMSR) Is Getting Closer
Less Than A Year! FDA’s QMSR Is Getting Closer The new Quality Management System Regulation (QMSR) ├óΓé¼ΓÇ£ FDA├óΓé¼Γäós long-awaited update to the medical device quality system requirements in 21 CFR Part 820 ├óΓé¼ΓÇ£ is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin […]
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