An AI Brain for Regulatory WorkMedical device regulatory professionals can leverage professional AI templates with their own internal documents to rapidly generate high-quality regulatory submissions — right inside Microsoft Word.
Powerful FeaturesAI-powered tools designed for medical device regulatory professionals
AI AssistantAI Chat AssistantAsk questions, get suggestions, and draft content with an AI assistant that understands regulatory context.
AI Chat Assistant — 1/3
MultilingualTranslationTranslate documents between languages with AI and DeepL integration, preserving regulatory terminology.
Translation — 1/4
Risk AnalysisMedical Device Risk AnalysisRun structured medical device risk analysis and identify hazards, harms, and controls faster.
Medical Device Risk Analysis — 1/2
Compliance SubmissionMDR/IVDR GSPR CopilotMap evidence to MDR/IVDR GSPR requirements and draft compliance-ready responses.
MDR/IVDR GSPR Copilot
More capabilities
Knowledge BaseBuild private knowledge bases from your files, URLs, and notes to enhance AI responses with your domain expertise.
Compliance ReviewUpload compliance standards and automatically review documents for missing sections and issues.
Excel Translation + AI FormulaeTranslate Excel content in batches and generate AI formulae from natural language prompts.
Web SearchLet the AI search the web for the latest regulatory updates and reference materials.
Ready to get started?Join regulatory professionals who trust RAQB to power their workflow.Get Started