Newsletter | April 4, 2026

04.04.26 -- March's Most Popular Articles & Solutions

FEATURED EDITORIAL

The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail

While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

MES Is Still In The CD ROM Era But The Data Architecture Has Moved On

Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

Diagnostics Rewired: From Tests To Lifelong Digital Twins

As routine labs, imaging, and information from wearables and the environment stream in, a digital twin can model trajectories and suggest next actions, turning diagnostics into a living operating system for care.

TOP INDUSTRY INSIGHTS

Cybersecurity And Medical Devices: Understanding Classes And Risk

A device's FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require independent security assessments to protect patient data and ensure compliance.

Rethinking Ethylene Oxide (EO) Sterilization

Lowering EO levels is possible without sacrificing sterility. Learn how calibrated PCDs and precise cycle control can reduce risk and streamline validation for more sustainable sterilization.

Considerations In Selecting A Biomaterial For Implantable Smart Devices

Smart implants revolutionize healthcare with embedded sensors for real-time monitoring. Polycarbonate urethanes offer biocompatibility, overcoming challenges with biomaterials for safer, efficient devices.

TOP RESOURCES

Why Biocompatibility Matters: Ensuring Medical Device Safety

Micro 3D Printing Handbook

ISO 80369 Compliant Connectors

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