Latest from Alexis
FDA Creates Class II Pathway for Non-Invasive Bone Growth Stimulators
FDA added 21 CFR 890.5870, establishing special controls for prescription devices that use electrical, magnetic, or ultrasonic fields to promote bone healing.
EU Standardizes Notified Body Timelines and Cost Transparency Under MDR and IVDR
Commission Implementing Regulation (EU) 2026/977 sets uniform timelines, cost transparency, and reporting requirements for notified bodies under MDR and IVDR.
LLM Hallucinations in Regulatory Work: Real Examples and How to Catch Them
LLMs hallucinate. In regulatory work, that is not just annoying — it is dangerous. Here are real examples from QARA work and practical habits to catch them.
When NOT to Use AI in Your Regulatory Work
Generalist AI keeps improving, but it is still far from enough for proper regulatory work. Here are five scenarios where you should not rely on it.
From Guidance Document to Requirements Checklist in 2 Minutes
A reusable prompt to extract every requirement from any regulatory guidance into a structured, traceable table. Applied here to the FDA Clinical Decision Support Software guidance.
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.
FDA Guidance for Cybersecurity in Medical Devices
We analyzed the updated FDA Cybersecurity guidance.
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
We built a redlining tool to understand the updated FDA Guidance about Wellness and Low-Risk Devices. Here's what changed.