How others handle the same documentation work

Every scenario is a real workflow, from the request to the finished output

Customer stories

Grouped by company stage — established, scaling and early-stage. Each story sets out the customer profile, how they worked before, what changed with Vizy Copilot, and where the figures come from.

Established

Auditing records that live in business systems: one chain, fully traceable

Profile: An established Class II device company running OA, ERP and CRM side by side, with business records scattered across them
Before: When a batch had to be audited, records were hunted across systems and stitched together by hand; asked who changed what and when, nobody could answer
With Vizy Copilot: Business records are filed automatically; controlled documents go through e-signature approval, recording signer, time and file hash
Result: Traceability 10x faster; who signed which version, and when, is one chain you can follow

Figures per the Product page, System & Data Integration and Electronic Signature Approval

Multi-centre clinical statistics: results you can recompute and defend

Profile: An established company running several trials at once, with statistics split between the clinical team and external statisticians
Before: Analyses ran as scripts on the statistician's machine; recomputing meant rerunning everything, and finding the original datasets and scripts during a deficiency letter took days
With Vizy Copilot: Statistics run inside the company's own environment (ANCOVA / MMRM / TEAE / Cox-KM), keeping the method, the dataset MD5 fingerprint and an audit trail together
Result: Results you can recompute and defend — evidence ready for deficiency letters and audits

Figures per the Product page, AI Clinical Statistics

Scaling

R&D and submissions in parallel: legacy documents migrated in one pass

Profile: A scaling company launching several products a year, with R&D and regulatory running in parallel
Before: Every project collected its own design documents, and submissions meant digging through each project folder again — duplicated effort, inconsistent answers
With Vizy Copilot: Legacy documents are imported in bulk and filed automatically; submission material is pulled straight from the archived R&D documents
Result: Legacy documents imported in bulk, digital migration completed quickly

Figures per the Product page, Batch Document Import

China and US submissions written in one conversation

Profile: A scaling company filing the same product with both the NMPA and the FDA
Before: Two dossiers written twice over, with different tables of contents and formats, and rework each time
With Vizy Copilot: One Q&A workflow produces both tables of contents, checked item by item against the official submission catalogue, with anything missing turned into a plain gap list
Result: Fewer gaps, fewer deficiency letters; with the mock review, 90% of potential nonconformities are caught early

Figures per the Product page, Smart Authoring for Regulatory Submissions and Smart Review & Simulated Audit

First time overseas: a 510(k) eSTAR package written in one pass

Profile: A scaling company whose product is already on the Chinese market and is preparing to enter the US, with only one or two people on the regulatory team who know the FDA
Before: Sections of the eSTAR template were filled in by hand — indications for use, device description, substantial equivalence discussion and the predicate comparison table each written separately — then checked against CDRH expectations by eye
With Vizy Copilot: Written section by section against the eSTAR structure (FDA 3514 cover sheet, indications for use, device description, substantial equivalence discussion, predicate comparison table), sourced directly from the company's archived DHF and technical requirements
Result: Fewer gaps, fewer deficiency letters; with the mock review, 90% of potential nonconformities are caught early

Figures per the Product page, 510(k) eSTAR Submission Package

Early-stage

Building a QMS from scratch: a four-layer document structure in two weeks

Profile: A newly founded Class II passive device company, under ten people, with no dedicated QA engineer
Before: QMS documents copied from templates did not match how the company actually operated, and there was no obvious starting point across manual, procedures, SOPs and records
With Vizy Copilot: Product technical files, the org chart and existing scattered documents are imported, and a four-layer structure is generated per ISO 13485 and GMP, written document by document
Result: QMS set up in two weeks; documents carry their own numbers, revisions and approval blocks, with no re-formatting needed

Figures per the Product page, Interactive Quality System Documents

A freshly written QMS, reviewed before anyone else sees it

Profile: An early-stage team whose QMS documents have just been written, with no internal audit experience yet
Before: The first internal audit had no checklist, with the constant worry of missing something — nonconformities were usually found only during an external inspection
With Vizy Copilot: A mock inspection is run against the QMS documents and regulatory requirements, listing each nonconformity and the order to fix them in
Result: 90% of potential nonconformities caught early; audit pass rate up 50%

Figures per the Product page, Smart Review & Simulated Audit

Customer stories have been anonymised and can be named with the customer's consent.

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