See Vizy Copilot in Action
From document generation to system management, from internal audits to registration — real scenarios, real demos
Core Feature Walkthrough
From document generation to system management, from internal audits to registration — real scenarios, real demos
Six Scenarios, One by One
Each scenario follows a real business workflow — from requirements to deliverables
Quality System Document Generation
Starting a medical device quality system from scratch is a massive undertaking. Vizy Copilot generates the full document set — quality manual, procedures, SOPs, record forms — aligned with ISO 13485 and NMPA GMP requirements. It tailors everything to your product type, company size, and org structure so the system actually fits how you work.
- One-click generation of the full four-tier document structure — manual, procedures, SOPs, records
- Auto-linked to NMPA/FDA/CE regulatory clauses — every requirement is traceable
- Customized to your product type and organization — no cookie-cutter templates
- Bring your own templates and approval workflows — it adapts to your process
DHF Smart Writing
Design History Files are the backbone of any registration submission and the first thing auditors look at. Vizy Copilot pulls from your real R&D process — design inputs, review notes, validation reports, test results — and assembles a complete, regulation-ready DHF. Design changes, verification loops, validation closures — all traced automatically.
- Pulls from your actual R&D files and real product data — no made-up content
- Covers the full design control flow: Input → Output → Verification → Validation
- Design change history auto-traced — auditors can see the full decision trail
- Meets NMPA and FDA 21 CFR 820.30 — built for companies planning to export
Batch Document Import
Most companies already have boxes of paper files or folders of Word docs scattered across drives. Vizy Copilot takes them all — Word, PDF, scans, Excel — identifies what each one is, extracts the key info, and files it into the right spot in your quality system. No rebuilding. No rewriting.
- Bulk upload Word, PDF, Excel, scanned files, and more
- Auto-identifies document type — quality manual, SOP, record — and files accordingly
- Converts scanned docs to AI-readable format so future writing can reference them directly
- Original version history and approval records stay intact
Smart Review & Simulated Audit
Every medical device company faces registration audits and unannounced inspections. Vizy Copilot runs through your entire system the way a real auditor would — clause by clause, document by document — and flags what's missing, what's weak, and what needs fixing before anyone shows up at your door.
- Auditor's-eye view of your system — finds the gaps before they do
- Every regulation clause marked compliant / partial / non-compliant
- Auto-generates internal audit reports, management reviews, and CAPA recommendations
- Issues ranked by severity — tackle the big ones first
System & Data Integration
Quality records live everywhere — HR systems, procurement, production, sales, warehousing. Vizy Copilot connects to your OA, ERP, and CRM systems and automatically generates the quality records those processes should have produced. Purchasing records, training logs, production logs, sales records — all filed, all traceable, no manual entry.
- Connects to your OA, ERP, CRM systems via API
- AI agents read business data and produce compliant quality records fast
- Full product lifecycle traceability — from raw material to end customer
- Eliminates manual transcription errors — accuracy goes way up
Registration Data Auto-Collection
Pulling together a registration submission means hunting through quality docs, DHFs, DMRs, and clinical evaluations. Vizy Copilot knows exactly what's needed for your product type and submission pathway, pulls it all together, auto-indexes it, and produces a complete submission package. You can even chat with it to refine documents in real time.
- Auto-generates the document checklist for your product — Class II/III, import, or innovation pathway
- Intelligently pulls content from existing quality docs and DHFs — nothing gets missed
- Drafts key materials through conversation — tell it what to change, it adjusts on the spot
- Exports a complete PDF submission package ready for the NMPA eRPS system
Try It Yourself
Download the desktop app and see what AI-powered documentation actually looks like