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Manufacturing Execution

Featured Articles

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.

February 3, 2026
Safety of AI in Medical Devices

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

By Pujitha Gourabathini

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.

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

By Randy Knotts

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

View More Operations Articles »

News & Views

  • 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

  • AI and Functional Precision Medicine: A Defining Moment for Pediatric Cancer Care

  • Significance of Harmonized standards

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

TOPICS

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  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
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Upcoming Events & Webinars

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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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