Latest from Alexis
EU Standardizes Notified Body Timelines and Costs
Commission Implementing Regulation (EU) 2026/977 sets uniform requirements for notified bodies under both MDR and IVDR.
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.
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.
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.