Category: Standards

Standards

Fresenius Kabi advises updating Ivenix Infusion System software to avoid two anomalies risking under- or over-infusion.

Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.

The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.

Congressman Joe Morelle introduced the Fair Repair Act, aiming to guarantee the right to repair products, excluding medical devices.

Microbot Medical has submitted a 510(k) notification for Liberty, its single-use robotic system for endovascular procedures.

ECRI has expanded its Total Systems Safety (TSS) and Human Factors Engineering (HFE) solutions to address preventable harm in healthcare.

Blue Goat Cyber’s Monthly Medical Device Cybersecurity Webinar Series provides guidance on regulations and cybersecurity for medical devices.