Medical Device Registration
Done by AI, Not by Hand
Forget generic AI that makes things up — Vizy Copilot is built for one industry, and it knows the rules inside out.
It reads your R&D files, learns your product, and drafts quality documents and submission materials that are actually ready to use.
No install, ready to use
Tell it what you need. It writes the quality manual, the SOPs, the submission files — most of the heavy lifting is already done.
It reads your actual R&D documents, understands your product the way your team does, and never invents facts.
Over 3,600 NMPA regulations, submission guidelines, and GB/YY technical standards — pre-loaded and ready to reference.
Every Doc, Every Stage — Covered
From setting up your quality system to filing for registration, from internal audits to ongoing document management — one platform, no switching between tools.
Quality System Document Generation
New company sets up quality system in 2 weeks. Traditionally takes 3–6 months.
DHF Smart Writing
A Class II DHF done in 2–3 days. Engineers save 80% of their time.
Batch Document Import
Dump your legacy docs in. It sorts, reads, and files them.
Smart Review & Simulated Audit
Catch 90% of issues before the auditor does. Audit pass rate up 50%.
System & Data Integration
Stop chasing records across systems. They get pulled in automatically.
Registration Data Auto-Collection
Your submission package, assembled automatically. One click to file.
Quality System Document Generation
New company sets up quality system in 2 weeks. Traditionally takes 3–6 months.
DHF Smart Writing
A Class II DHF done in 2–3 days. Engineers save 80% of their time.
Batch Document Import
Dump your legacy docs in. It sorts, reads, and files them.
Smart Review & Simulated Audit
Catch 90% of issues before the auditor does. Audit pass rate up 50%.
System & Data Integration
Stop chasing records across systems. They get pulled in automatically.
Registration Data Auto-Collection
Your submission package, assembled automatically. One click to file.
Quality System Document Generation
New company sets up quality system in 2 weeks. Traditionally takes 3–6 months.
DHF Smart Writing
A Class II DHF done in 2–3 days. Engineers save 80% of their time.
Batch Document Import
Dump your legacy docs in. It sorts, reads, and files them.
Smart Review & Simulated Audit
Catch 90% of issues before the auditor does. Audit pass rate up 50%.
System & Data Integration
Stop chasing records across systems. They get pulled in automatically.
Registration Data Auto-Collection
Your submission package, assembled automatically. One click to file.
Quality System Document Generation
New company sets up quality system in 2 weeks. Traditionally takes 3–6 months.
DHF Smart Writing
A Class II DHF done in 2–3 days. Engineers save 80% of their time.
Batch Document Import
Dump your legacy docs in. It sorts, reads, and files them.
Smart Review & Simulated Audit
Catch 90% of issues before the auditor does. Audit pass rate up 50%.
System & Data Integration
Stop chasing records across systems. They get pulled in automatically.
Registration Data Auto-Collection
Your submission package, assembled automatically. One click to file.
Quality System Document Generation
New company sets up quality system in 2 weeks. Traditionally takes 3–6 months.
DHF Smart Writing
A Class II DHF done in 2–3 days. Engineers save 80% of their time.
Batch Document Import
Dump your legacy docs in. It sorts, reads, and files them.
Smart Review & Simulated Audit
Catch 90% of issues before the auditor does. Audit pass rate up 50%.
System & Data Integration
Stop chasing records across systems. They get pulled in automatically.
Registration Data Auto-Collection
Your submission package, assembled automatically. One click to file.
Your R&D Secrets Stay Yours
Experimental data, product drawings, source code — these are the heart of your business.
We lock them down from every angle: how they're stored, how the AI handles them, and where everything runs.
Your Data Lives in Its Own Container
Every company gets a dedicated, isolated storage space. No one else can see in — period.
AI That Doesn't Learn From You
We run our own models in a controlled environment. Your data is never sent to model providers for training. (Not available during Beta)
Deploy Your Way
Three options — from fully managed to completely on your own servers.
Fully Managed
For teams that just want it to work
We host everything — your documents, your data. Zero maintenance on your end. Just log in and start working.
Data Private Deployment
For teams that keep data in-house
Your data stays in your own database. The platform handles the AI calls — nothing sensitive ever leaves your network.
Full Private Deployment
For teams that want total control
Everything runs on your servers — data, AI models, all of it. You own the whole stack.
Documents That Look and Feel Right Out of the Box
Every file Vizy Copilot generates follows your company's quality manual — proper headers, version tracking, approval signatures. No reformatting. Just open and use.
- Standard medical device document headers with auto-generated title page and table of contents
- Relevant regulations and standards cited automatically where they belong
- Your company logo and branding on every document
- Multi-level approval signature blocks included
- Version history tracked automatically — no more guessing what changed
Where We Stand
Since official launch
Questions We Get a Lot
Quick answers before you jump in
See What It Can Do
Free to try — let us show you how much paperwork AI can take off your plate