Medical Device Registration
Done by AI, Not by Hand
An industry agent that knows the regulations — no generic-LLM hallucinations, just precise submission documents.
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.
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 5,000 NMPA regulations, submission guidelines, and GB/YY technical standards — pre-loaded and ready to reference.
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
You can deploy the model in a controlled environment. Your data is never sent to model providers for training, so your core IP stays confidential.
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
* Companies that signed a trial agreement (online or offline) and had an enterprise account activated, or that have signed on as Vizy Copilot customers.
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