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 ...

Medical manufacturing requires more than production capacity. Success depends on having a manufacturing partner that understands the entire path from product design and material selection to tooling, ...

As medical devices become smaller, more integrated, and more functionally dense, micro insert molding is helping manufacturers combine polymer and metal functionality within a single precision ...

Loveland, Colorado – August 18, 2026 — Nordson MEDICAL, a Nordson Company (Nasdaq: NDSN), is thrilled to expand its Divert™ line of stopcocks with Divert™ ULTRA, a new line of ultra-high-pressure ...

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 ...

Regulatory risk originates predominantly on the shop floor, where human error, paper documentation, and disconnected systems turn small operational gaps into critical compliance failures. Data ...

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 ...

Bringing a medical device or delivery system component from early concept to commercial production requires more than individual technical capabilities. It takes coordinated expertise across materials ...