This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

IVEK's MICROSPENSE AP is a pumping apparatus specifically designed for small volume liquid metering and dispensing. This motor base is controlled by an IVEK controller and simultaneously imparts a ...

These high-performance batteries are based on lithium-iodine or lithium-manganese dioxide. They feature high volumetric energy densities and low self-discharge. They’ve been specifically designed for ...

Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs. Many manufacturing execution system (MES) ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu ...

Simplify the complexity of combination product development by partnering for integrated support across device design, ...

Ethylene vinyl acetate (EVA) has a long and successful history of innovation in medical packaging, medical devices, and pharmaceutical applications. In fact, EVA has been an innovative force in those ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...