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FEATURE ARTICLE

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

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.  



FEATURED CONTENT

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.

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.

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

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.  

Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

By Kaleb Averell

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.

Taking Lean Manufacturing to the Next Level

By Matt Stekier

The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action.

Why Few MedTech Sales Teams Are Using AI Where It Matters Most

By Lee Smith

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?

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

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.

SaMD Readiness

Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development

By Shreya Sridhar

Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete?






MEDTECH VIEWPOINT

Devices are Getting Smarter, Making Materiovigilance Evolve Faster

By Dr. Padmalakshmi Jnaneshwar

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?

The Interface is the Risk: A MedTech Blueprint for AI and System Integration

By Aneesh Deshpande

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&V Engineers between exploding complexity and compressed timelines.

AI in the EHR

Applying Agentic AI to Healthcare Delivery: The Key to True Transformation

By Jaimon Jose

MTI Viewpoints Insights shared by industry relative to healthcare and...

Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and...

ASK THE EXPERT

medtech development

Product Development Outsourcing Needs Speed, Safety & Certainty

Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.

medtech design standards

4 FAQs to Notified Bodies

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

Product Lifecycle Management

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

NEWS

  • Zimmer Biomet to Hire 500 in India as New Bengaluru Technology Centre Drives AI and MedTech Innovation

  • AdaptHealth Investigates Data Breach After Social Engineering Attack, Possible Link to ShinyHunters Emerges

  • CMS Proposes TAVR Medicare Coverage is Potential Boost for Edwards Lifesciences

  • Medtronic Advances Hugo Robotic Surgery Platform with Key FDA Filings and Product Approvals

  • Medtronic Posts Strongest Revenue Growth in a Decade, Driven by Cardiovascular and Surgical Businesses

  • Boston Scientific Plans Indiana Distribution Center, 300 New Jobs

  • Artivion Completes Endospan Acquisition, Expands Aortic Arch Portfolio With FDA-Approved NEXUS System

  • Global MedTech Contract Manufactures Finalize Merger

  • Carl Zeiss Meditec Plans Up to 1,000 Job Cuts Amid Restructuring Effort

  • Signatera CDx Gets FDA Nod as Companion Diagnostic for Muscle-Invasive Bladder Cancer

  • Boston Scientific announces strategic investment in MiRus LLC

  • FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

  • FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation

  • Roche acquires PathAI to transform AI-driven diagnostics

  • Trump Planning to Fire FDA Commissioner Marty Makary


Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle


On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?









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TOPICS

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  • MedTech Economics
  • Manufacturing Execution
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  • Quality/Regulatory

Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle

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Boost Product Quality with Integrated ALM and PLM
Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.

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