Quick Start

Product Overview

Reguverse Assistant is an AI-powered medical device regulatory platform delivered as a Microsoft Word Add-in. It helps Regulatory Affairs (RA) professionals efficiently complete clinical evaluations, compliance document generation, and post-market surveillance.

Core Capabilities

Module	Description	Plans
EU MDR Clinical Evaluation	10-step workflow generating CEP/CER/DCR	All plans
GSPR Compliance	Annex I full-clause compliance analysis	Pro / Max / CRO
Risk Management	Hazard identification, RCM, risk matrix	All plans
PMS Plan	Post-market surveillance plan	Pro / Max / CRO
PMCF Plan	Post-market clinical follow-up plan	Pro / Max / CRO
Clinical Evaluation Update	Periodic clinical evaluation update	Pro / Max / CRO
PMCF Evaluation Report	Post-market clinical follow-up report	Pro / Max / CRO
Periodic Safety Update Report	PSUR generation	Pro / Max / CRO
NMPA Registration	eRPS chapter-based submission materials	Pro / Max / CRO
Device Classification	MDR/IVDR Annex VIII classification	All plans
Equivalent Device Research	510(k) equivalence analysis	All plans
Translation	Medical device regulatory document translation	All plans
EUDAMED UDI Bulk Upload	Batch XML generation for UDI-DI	All plans
Knowledge Base	EU MDR/MDCG full-text search	All plans

Supported Regulatory Frameworks

• EU MDR (Regulation (EU) 2017/745)
• NMPA -- China National Medical Products Administration
• FDA -- US Food and Drug Administration (planned)

Workflow

Install → Register → Create Project → Execute Steps → Generate Documents → Export to Word

1. Install

Download the installer for your platform or use the automated installation script. You can also use the web version directly in your browser.

→ Install Plugin

2. Register

Create an account in the plugin. CN personal users require phone verification and identity verification; enterprise users require enterprise certification and contract signing.

→ Register & Login

3. Create Project

Select regulatory framework (EU MDR / NMPA), fill in device information, create a project.

→ Create EU MDR Project

4. Execute Steps

Follow the workflow guide step by step. AI generates content for each step which you can review, edit, and approve.

5. Generate Documents

After all steps are approved, generate compliance documents with one click and insert into Word or download.

→ Generate Documents

System Requirements

Platform	Minimum Requirements
Windows	Windows 10+, Microsoft 365 or Office 2019+
macOS	macOS 12+, Microsoft 365 for Mac
Web	Modern browser, access https://app.reguverse.com/

Network Requirements

Reguverse Assistant requires a stable internet connection to access AI services. Minimum 5 Mbps bandwidth recommended.

Next Steps

• Install Plugin -- Get and install the Word add-in
• Register & Login -- Create your account
• Plans & Pricing -- Compare plans and features