Regulatory & Product Insights

Field notes on risk, regulatory work, and where AI actually helps.

Practical breakdowns of FMEA, ISO 14971, MDR/IVDR submissions, and product updates — written by the RA team building RAQB.
Product Updates

We taught AI to draft your FMEA. Here's why that's harder than it sounds.

Hazard identification depends on who's in the room. We built Risk Analysis to fix the five failure modes of doing FMEA by hand — and drew hard lines on what the model never gets to decide.
Bohris · RAPS Member · RAC (Devices)12 min read · Aug 17, 2026
The generated FMEA worksheet in Excel, showing hazard IDs with residual severity and probability ratings, colour-coded risk acceptability, and benefit-risk columns.