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MedTech Intelligence

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AI-Assisted Triage: Accelerating Post-Market Surveillance While Eliminating Reporting Blind Spots

<p>Complaint volumes have outgrown manual triage, and medical device companies are turning to AI to keep up. The speed gains are real, but used carelessly the same tools can bury a reportable event at the bottom of a queue while the MDR clock runs. This piece maps where AI genuinely helps in post-market surveillance, where human judgment has to stay, and what validation, monitoring, and audit trails a defensible program needs. It is grounded in the current regulatory frame, including the QMSR and FDA's new inspection program (CP 7382.850) that took effect February 2, 2026, 21 CFR Part 803 reporting timelines, and ISO 13485 software validation expectations. It includes a practical table drawing the line between tasks that are safe to automate and decisions that must stay human-owned. The intended audience is quality, regulatory, and post-market surveillance professionals in the medical device industry.</p> <p>The post <a href="https://medtechintelligence.com/feature_article/ai-assisted-triage-accelerating-post-market-surveillance-while-eliminating-reporting-blind-spots/">AI-Assisted Triage: Accelerating Post-Market Surveillance While Eliminating Reporting Blind&nbsp;Spots</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/20
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Sensors at the Edge: Powering Smarter Healthcare

<p>As healthcare shifts towards remote monitoring, connected devices and decentralized care, sensor technologies are becoming increasingly foundational to how medical devices collect, validate and transmit critical information. From remote patient monitoring and at-home care to connected medical devices and robotic-assisted surgery, sensing technologies can help enable earlier detection, more reliable clinical data and better-informed decision making.</p> <p>The post <a href="https://medtechintelligence.com/feature_article/sensors-at-the-edge-powering-smarter-healthcare/">Sensors at the Edge: Powering Smarter&nbsp;Healthcare</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/19
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Devices are Getting Smarter, Making Materiovigilance Evolve Faster

<p>According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline?</p> <p>The post <a href="https://medtechintelligence.com/viewpoint/devices-are-getting-smarter-making-materiovigilance-evolve-faster/">Devices are Getting Smarter, Making Materiovigilance Evolve&nbsp;Faster</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/19
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FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

<p>GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.  </p> <p>The post <a href="https://medtechintelligence.com/feature_article/fda-seeks-public-feedback-to-inform-regulatory-approach-for-generative-ai-enabled-medical-devices/">FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical&nbsp;Devices</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/19
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What 524B and QMSR Change About Medical Device Risk

<p>What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.</p> <p>The post <a href="https://medtechintelligence.com/feature_article/what-524b-and-qmsr-change-about-medical-device-risk/">What 524B and QMSR Change About Medical Device&nbsp;Risk</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/10
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Taking Lean Manufacturing to the Next Level

<p>The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action.</p> <p>The post <a href="https://medtechintelligence.com/feature_article/taking-lean-manufacturing-to-the-next-level/">Taking Lean Manufacturing to the Next&nbsp;Level</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/10
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Why Few MedTech Sales Teams Are Using AI Where It Matters Most

<p>A MedTech survey revealed that most sales teams are not using AI for strategic purposes, such as identifying opportunities, prioritizing accounts, or research. Instead, AI is mostly deployed to complete administrative tasks, such as drafting emails and summarizing meetings. Why is more needed?</p> <p>The post <a href="https://medtechintelligence.com/feature_article/why-few-medtech-sales-teams-are-using-ai-where-it-matters-most/">Why Few MedTech Sales Teams Are Using AI Where It Matters&nbsp;Most</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/10
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Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible

<p>Emerging medical-device risks are often missed because early warning signs are fragmented across complaints, manufacturing, suppliers, returned products, clinical observations, and other data sources; not immediately as statistically significant trends. An engineering-centered, cross-functional approach connecting these weak signals to underlying mechanisms sooner, can improve designs, verification, manufacturing controls, and risk management before isolated issues become widespread quality problems.</p> <p>The post <a href="https://medtechintelligence.com/feature_article/why-organizations-miss-emerging-product-risk-understanding-the-engineering-mechanisms-that-remain-hidden-long-before-complaint-trends-become-visible/">Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become&nbsp;visible</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/9
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The Interface is the Risk: A MedTech Blueprint for AI and System Integration

<p>Catastrophic failures rarely stem from isolated hardware bugs. They breed where hardware, firmware, wireless telemetry, and clinical workflows intersect. These silent data integrity failures can invalidate entire research efforts without real-time detection, squeezing V&#038;V Engineers between exploding complexity and compressed timelines.</p> <p>The post <a href="https://medtechintelligence.com/viewpoint/the-interface-is-the-risk-a-medtech-blueprint-for-ai-and-system-integration/">The Interface is the Risk: A MedTech Blueprint for AI and System&nbsp;Integration</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/6
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Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development

<p>Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete?</p> <p>The post <a href="https://medtechintelligence.com/feature_article/beyond-the-status-report-using-llms-to-reveal-the-true-state-of-samd-development/">Beyond the Status Report: Using LLMs to Reveal the True State of SaMD&nbsp;Development</a> appeared first on <a href="https://medtechintelligence.com">MedTech Intelligence</a>.</p>

2026/8/3
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