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

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

Low-code MES promises speed, but agility comes from ownership. Composable, no-code approaches give operations teams the ...

Traditional MES platforms were built for stable environments that no longer exist. Manufacturers are now adopting composable ...

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

Build regulatory strategy into your company from day one — not as support, but as a core driver of value, risk management, ...

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 ...

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 ...

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 ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

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 ...