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

Still Searching Regulatory Websites Manually? Meet RAQB's AI-Powered Regulatory Knowledge Base

45 regulatory knowledge bases across 10 countries and specialized topics, built for AI retrieval instead of human reading — noise removed, structure reconstructed, tables and flowcharts repaired, chunked by regulatory clause, and cited back to source. Free to try with 500 signup points.
Bohris · RAPS Member · RAC (Devices)9 min read · Sep 6, 2026
Summary card for RAQB's regulatory knowledge bases: 45 AI regulatory knowledge bases covering 10 countries and specialized topics, built for AI retrieval and source-grounded answers.
Cover: a 30-page IVD clinical protocol taken through English-to-French translation and terminology review against the product IFU.
Case Studies

A 30-page IVD clinical protocol, translated and terminology-checked in about fifteen minutes

Translating English to French is the easy part. Keeping the layout intact and every product name and assay term aligned with the French IFU is where the day goes. Here's the workflow that collapsed it.
Bohris6 min
Summary card for RAQB's public regulatory knowledge bases: 42 AI medical device regulatory knowledge bases covering 8 countries and regions — USA, EU, UK, Brazil, China, India, Australia, Korea, Argentina — with 1,588+ regulations, official guidelines and technical guidance, continuously updated and sourced from official authorities.
Product Updates

The AI knowledge base for global medical device regulations

42 public knowledge bases across 8 countries and regions, holding 1,588+ regulations, official guidelines and technical guidance — OCR-cleaned, table-repaired, and chunked by Article and Clause so every answer cites a passage you can check. Free to query with 500 signup points.
Bohris11 min
Product Updates

The regulatory library you don't have to maintain

Looking up regulations across jurisdictions is daily RA work, and a tidy folder of PDFs does not solve it — raw regulatory PDFs are noisy, their tables come out mangled, and AI answers built on them are confidently wrong. So we cleaned and indexed the corpus ourselves.
Bohris11 min
The completed GSPR checklist in Excel, showing applicability calls with justifications, matched standards, and evidence references alongside each Annex I requirement.
Regulatory

The gaps in filling out a GSPR checklist by hand, and how we closed them with AI

A few hundred Annex I sub-clauses, each needing an applicability call with a defensible reason attached. Three steps, and you get a finished MDR or IVDR workbook back.
Bohris7 min
The generated FMEA worksheet in Excel, showing hazard IDs with residual severity and probability ratings, colour-coded risk acceptability, and benefit-risk columns.
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.
Bohris12 min