Now that QMSR is live, are you actually seeing "MDF" gaps in your legacy DHFs?

Hey r/MedicalDevices,

Now that we are officially a month into the mandatory QMSR era (Feb 2 deadline), I’ve been running a few dozen technical files through a deterministic audit engine I built.

The Trend: Everyone talked about 'transitioning,' but the actual friction I'm seeing is in the mapping of legacy 21 CFR 820 citations to the new ISO 13485-incorporated requirements. Specifically, the 'Risk-Based' record access for internal audits is catching people off guard.

I built a self-service tool (MedComplyAI) that uses a 9P/2G deterministic engine (no LLM hallucinations) to find these gaps instantly. I'm curious—for those of you currently undergoing audits or remediating files, where are you finding the biggest logic gaps?

If you want to run a quick gap check on a specific file to see where you stand:pro.medcomplyai.com

Looking for some 'war stories' or technical friction points you're hitting with the new MDF structure.