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

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 ...

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 ...

Standard extraction protocols routinely fail tissue-derived products, hydrogels, absorbables, and silicone implants. Learn ...

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 ...

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 ...

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 ...

If your devices are sterilized with ethylene oxide (EtO), ISO 10993-7:2026 changes how you justify your residual acceptance criteria, and the shift is more substantive than a simple limit update.

If you're managing ethylene oxide (EtO) sterilization for medical devices, residual control is probably more complex than your current process accounts for. Most teams focus on aeration time, but that ...

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, ...

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 ...

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 ...