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 ...

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 ...

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

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 ...

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 ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

The medical device market in India is one of the best places for the world to tap into since the early 2000s. Many are watching the evolution of the medical device industry in India, with McKinsey and ...

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 — ...