The Artifice Platform
Quality, production and sales on one platform.
Artifice is the configurable SaaS platform for regulated manufacturers. Start with a ready-made eQMS, then shape every object, form and workflow to the way you work.
From nonconformance to closed CAPA, in one thread.
NCMRs, CAPAs, complaints, deviations, audits, management review and risk — linked, staged and signed. Built for ISO 13485, MDSAP and 21 CFR Part 11.
Built for medical device quality systems
- ISO 13485
- MDSAP
- 21 CFR Part 11
- 21 CFR Part 820
Platform
One configurable platform, not five tools glued together.
Quality, production and sales share the same records, the same people and the same audit trail. When the way you work changes, you change the platform — not your process.
Your objects, your fields
Define objects, fields and page layouts without code. Your parts, suppliers or sites become first-class records.
Flows and wizards
Guide people through each step with wizards, and let flows take care of what happens next.
Documents from records
Quotes, travelers and certificates from PDF templates — every generated document gets its own version.
Packages to start from
Install Document Control, Quality Assurance, Production and Suppliers, then adapt them. Upgrades arrive as versioned releases.
Search, lists and boards
Find any record with ⌘K. Work in list views, or drag cards across a board to change their stage.
Overviews that update themselves
Every module opens on live counts, charts and what is due — no report to run, no export to refresh.
Assistant
AI that proposes. People who decide.
The Assistant works inside your instance, on your records, with your permissions. In a regulated system, every change still needs a person behind it.
- Ask in plain language — "raise a CAPA from NCMR-0142 and assign the actions".
- The Assistant saves nothing on its own. It sends a Proposal, and you approve or reject the whole set.
- Connect Claude or another AI tool through MCP with an AI Connection. It acts as you, with exactly your roles.
- Schedule recurring work, and approve narrow kinds of edits in advance.
Compliance and hosting
Ready for the audit before the auditor is.
Artifice is built for ISO 13485 §4.2.4, MDSAP and 21 CFR Part 11 from the data model up — not bolted on afterwards.
Your own instance
Every customer gets an isolated deployment with its own database, file storage and hostname. Hosted by us, never shared.
E-signatures bound to content
Each signature records its meaning, the printed name, the server time and a fingerprint of exactly what was signed.
A complete history
Every record keeps who changed what, and when — including changes made through the Assistant.
Releases you validate
Packages ship as versioned releases. You choose when to adopt one, and validate it for your quality system first.
See Artifice on your own processes.
Tell us what you build and where it hurts today. We will walk you through the platform with your records, not a generic script.
Book a demo