Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

These delivery systems frequently employ fittings called luer connectors to link various system components. Unfortunately, because luer connectors are ubiquitous, easy-to-use, and compatible between ...

Castor is a clinical trial platform for medical device, biopharma, diagnostics, and academic research teams. It unifies electronic data capture, ePRO, eConsent, and randomization in one system, and ...

Standard extraction and biocompatibility workflows were not built with tissue-derived products, hydrogels, absorbables, or silicone implants in mind. Apply them without modification and the failures ...

Per- and polyfluoroalkyl substances (PFAS) — commonly referred to as “forever chemicals” — are increasingly under public and regulatory scrutiny due to their persistence in the environment, potential ...

The majority of IV infusions are performed in acute care settings, such as hospitals and other out-patient centers. 1 Infusion of medication is a common form of treatment in hospitals across the ...

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 — ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

ISO technical committee (ISO/TC) 194, Biological and clinical evaluation of medical devices, subcommittee (SC) 1, Tissue product safety, in collaboration with the European Committee for ...

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 ...