Regulatory resources

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.

Clinical Decision Support Software

FDA Guidance for Cybersecurity in Medical Devices

Redline Fridays

FDA Guidance for Cybersecurity in Medical Devices

We analyzed the updated FDA Cybersecurity guidance.

MDCG 2025-7 Rev. 1

Redline Fridays

MDCG 2025-7 Rev. 1

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

FDA Guidance for General Wellness

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.