One Platform, Full-Link Medical Device Docs
From quality system setup to registration submission, Vizy Copilot covers the entire medical device documentation lifecycle
The Old Way vs. Vizy Copilot
System Architecture
End-to-End Document Workflow
Deployment Options
Vizy Copilot offers flexible deployment models to meet different compliance and infrastructure needs
Cloud deployment works out of the box; private deployment keeps data entirely in-house
“Our company is strict about information security and bans uploading internal files to AI. Vizy Copilot's consultants deployed the model and the servers inside our own environment — now both documents and AI stay in-house, and that is when our efficiency actually took off.”
QMS build-out
Build a QMS from the ground up
Interactive Quality System Documents
Interactive quality system documents, with AI answers that help your team actually run the system
Building a medical device quality system from scratch is a heavy lift. Based on ISO 13485 and NMPA GMP requirements, Vizy Copilot generates the full document architecture — quality manual, procedures, SOPs and record forms — in about 20 minutes. Unlike a static template it does more than output documents: you can ask questions about any document at any time, and the AI answers in the context of your product type, company size and org structure, telling the team what to actually do — so a small company's quality system genuinely lands and stays in use instead of living on paper. It also helps you revise the system and add MDSAP and QMSR clauses for overseas markets.
- Interactive Quality System Documents
- Smart Review & Simulated Audit
- System & Data Integration
- Electronic Signature Approval
Regulatory submission
Prepare and file regulatory dossiers
Smart Authoring for Regulatory Submissions
A layered AI engine that fits each submission scenario — drafts faster, with far fewer gaps and deficiency letters
Writing registration dossiers is hugely labour-intensive: staff dig through the quality system documents and the DHF, then re-cut the content and format for each submission scenario — which is where missed sections, mismatched content and the resulting deficiency letters come from. Vizy Copilot drops the fixed-template approach. It carries a layered compliance writing system covering the 170-plus medical device submission writing rules required by different regulators, and for each submission region and product type it matches its own section order, mandatory items, writing taboos and reviewer-facing language style — covering active, non-active and IVD devices alike. When a domestic product goes overseas, it also avoids the deficiency risk of mechanically translating the domestic dossier and submitting it as-is. Once your DHF is done, the system breaks the work down item by item against the relevant regulatory submission catalogue and drafts it through a professional workflow. When the draft is complete it self-checks against the review points, lists what is missing or wrong and produces a remediation list — cutting the odds of a deficiency letter.
- Smart Authoring for Regulatory Submissions
- DHF Smart Writing
- Batch Document Import
Global compliance
Compliance for overseas markets
510(k) eSTAR Submission Package
Written section by section against the eSTAR structure, sourced from your own DHF and technical requirements
A 510(k) eSTAR is a dynamic form with a fixed section structure, and filling it in by hand fails in two familiar ways: a section gets missed, and nobody can say where a statement came from. Vizy Copilot works through the eSTAR structure item by item — the FDA 3514 cover sheet, indications for use, device description, substantial equivalence discussion and the predicate comparison table. For each one it first settles whether the item is required, what it should say and which regulation it rests on, then pulls the material from your archived DHF and technical requirements, so every statement traces back to a source. Before submission it self-checks against CDRH expectations and hands you a plain gap list. Your documents never leave your own environment.
- 510(k) eSTAR Submission Package
- One DHF, many markets
Clinical trials（coming soon）
Protocol writing, ongoing monitoring and statistics
AI Clinical Statistics
A low-cost, compliant statistics pipeline — traceable and recomputable
Clinical statistics brings three problems at once: high cost, a high bar to entry and poor traceability. Commercial statistics licences are expensive; open-source tooling demands strong people and its compute environment cannot be reproduced in a compliant way; outsourcing brings data-leak risk, slow back-and-forth and a poor fit to your protocol. Vizy Copilot is launching an AI-Agent-based clinical statistics solution — stay tuned.
- AI Clinical Statistics
- Clinical Trial Protocol Writing
Looking for the solution that fits your device?
Tell us your device type and what documents you already have — an advisor will suggest the concrete next step.