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

By Binitkumar M. Vaghani

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.

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Sensors at the Edge: Powering Smarter Healthcare

By Daraius Patell

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.

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Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

By Kaleb Averell
Balancing Cyber Risk

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.

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post market surveillance

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

By Aalap Patel, MS, CQE, CSSBB
post market surveillance

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.

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post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB
post market surveillance

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness.

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AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Anthony Watson, Geethapriya (Priya) Setty, Jay Vaishnav, PhD
AI Compliance in Medical Devices

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

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