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 ...

This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained. CSV Assumes The AI System Sits Still — It Doesn't. The ...

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 ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the ...

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 ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...

Mesa PCDs (Process Challenge Devices) are innovative, patented tools specifically engineered to support the rigorous demands of ethylene oxide (EO) sterilization processes. These devices incorporate ...

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

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 ...

Risk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. 1 The main purpose of this analysis is to identify all ...