For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date.

Engineers with direct exposure to failure outcomes are more likely to build risk mitigation in from the start, not bolt it on ...

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 ...

Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. Send the instructions for use (IFU), labeling, protocol, investigator brochure, or ...

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 ...

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, ...

Digital health is full of promise but short on proof. Many products struggle to demonstrate the clinical rigor needed to earn trust, secure reimbursement, and sustain long-term growth. In this ...

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 ...

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 ...

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 ...