Storke

AI-Powered Regulatory Writing, Right Inside Microsoft Word

Storke is an AI copilot built specifically for medical device regulatory professionals. It lives in your Word sidebar, so you never have to leave the document you're working on.

What Storke Does

Chat — Ask regulatory questions and get instant, context-aware answers. Storke reads your current document, so you can ask things like "What classification would this device fall under?" or "What are the essential requirements I'm missing?" without copying and pasting text back and forth.

Draft — Generate regulatory content and insert it straight into your document. Fill in technical file templates, draft sections of clinical evaluation reports, risk management plans, and more — without starting from a blank page. Select existing text to rewrite or refine it, or let Storke draft entire sections from scratch.

Clinical Literature Search — AI-assisted literature reviews for clinical evaluation, directly from your sidebar.

Regulation Knowledge Engine — Get cited answers grounded in UK MDR and associated guidance documents. No more digging through legislation to find the clause you need.

Who Is Storke For?

• Regulatory affairs consultants who draft technical documentation across multiple clients and want to move faster without sacrificing quality.
• Medical device manufacturers preparing submissions for UK MDR, EU MDR, or FDA pathways.
• Quality and compliance teams maintaining and updating regulatory documentation.

Why Storke?

• Purpose-built for medtech regulatory work — not a generic AI writing tool.
• Works inside Microsoft Word, where you already write your documents.
• Fast, responsive AI that keeps up with your workflow.

Coming Soon

• ISO 13485, ISO 14971 & more standards added to the knowledge engine.
• EU MDR, FDA & more regulatory frameworks added to the knowledge engine.
• Compliance Check — Analyse your document against specific regulatory requirements.
• Gap Analysis — Identify what's missing from your documentation.
• And more.