Latest from Alexis

Redline Fridays
Clinical Decision Support Software
FDA updated the CDS guidance twice in January 2026. We redlined the changes so you don't have to read 30+ pages.

Redline Fridays
FDA Guidance for Cybersecurity in Medical Devices
We analyzed the updated FDA Cybersecurity guidance.

Redline Fridays
MDCG 2025-7 Rev. 1
We tackled MDCG 2025-7 Rev. 1 to see exactly what changed between July and December 2025.

Redline Fridays
FDA Guidance for General Wellness
We built a redlining tool to understand the updated FDA Guidance about Wellness and Low-Risk Devices. Here's what changed.
