Storke – AI co-pilot for medical device regulation inside Microsoft Word

Summary: Storke integrates an AI regulatory knowledge engine within Microsoft Word to assist with medical device compliance. It supports EU MDR, UK MDR, FDA, ISO 13485, ISO 14971, and major MEDDEV and MDCG guidances, automating tasks like clinical evaluation plans, literature reviews, GSPR checklists, and document compliance reviews.

What it does

Storke uses AI to generate and review regulatory documents directly in Word, covering multiple global medical device regulations and guidances. It automates complex compliance tasks that typically require extensive consultant time.

Who it's for

It is designed for medical device developers and regulatory professionals managing compliance documentation across jurisdictions.

Why it matters

Storke reduces the time and cost of regulatory compliance, accelerating the approval process for medical devices.