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Manufacturing Execution

Featured Articles

July 7, 2026
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 (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.

June 29, 2026
AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Geethapriya (Priya) Setty

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.

May 11, 2026
Cerevasc

An Endovascular Approach to Neurological Diseases Can Shift the Treatment Paradigm

By Dan Levangie

Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach.

April 30, 2026

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

April 20, 2026
navigating regulatory strategy

Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices

By Jonathan Messer

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.

April 1, 2026

The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms

By Shreya Sridhar

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.

March 13, 2026

The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices

By Partha Anbil

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration's (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

View More Operations Articles »

News & Views

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

  • Global MedTech Contract Manufactures Finalize Merger

  • Medtronic Continues Cardiovascular Care Growth with Completion of CathWorks Acquisition

  • The Structural Tension at the Heart of MedTech

  • Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

  • Philips unveils Rembra CT for acute and high-demand imaging environments

  • BD Gets CE Mark for Revello Vascular Covered Stent

  • Why Digital Tool are Needed to Cope with Increasing Pressures in MedTech Innovation

  • Catalyst OrthoScience gets FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty

  • FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies

Upcoming Events & Webinars..

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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






Operations Archive

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  • MedTech Economics
  • Manufacturing Execution
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Upcoming Events & Webinars

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