Tag Archives: post-market surveillance

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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Safety of AI in Medical Devices

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini
Safety of AI in Medical Devices

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

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Post-market surveillance

Reliable Active Surveillance: RWE for MedTech

By Amelia Hufford, PhD, Phillip Stoltzfus
Post-market surveillance

As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.

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Smridula Hariharan

Ask the Expert: PMCF implementation under EU MDR

By MTI Marketing Staff
Smridula Hariharan

Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).

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