Managing global PFAS regulations demands a proactive strategy. Identifying and mitigating both intentional and unintentional ...

In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling ...

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards. Here are practical tips to build ...

Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad ...

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 ...

Pressures on healthcare systems are set to become worse with aging populations requiring round-the-clock care and an exponential increase in chronic diseases. Technology-led smart solutions are ...

This article is the first of a two-part series; read part two here. The U.S. Food and Drug Administration (FDA) is increasing demands [i],[ii] for drug delivery device developers to demonstrate the ...

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 ...

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 — ...

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The ...

The key takeaway is that data science cannot work in a vacuum in developing machine learning models for medical devices. It’s critical that a multidisciplinary team of scientists, engineers, ...

This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...