Enclave for Medical Device & Life Sciences

Private AI for design history files and customer IP.

For device makers, contract manufacturers, and product-development firms. A private AI server installed in your office, with nothing to send to an outside AI provider.

21 CFR 820 / QMSRISO 13485ISO 14971Customer NDAs & quality agreements
The problem

Design history files, test reports, and customer drawings are often covered by NDAs and quality agreements that never contemplated a third-party AI vendor. One upload to a public tool can put years of IP somewhere you can’t control.

How Enclave helps

AI your team can actually use, with data that stays put.

Customer IP stays in-house

Your engineers get AI drafting and document Q&A without sending customer files to an outside AI company.

Supports your quality system

Access control by group, audit trails of who asked what, and a documented data flow your QA team can review.

Speeds the paperwork

Draft design-review checklists, hazard-analysis tables, test protocols, and 510(k) summaries from your own documents.

Real work, on day one

What your team will ask it.

During your demo we load public documents from your world and run these live, so you can judge the quality yourself.

Watch the 2-minute demo
Summarize a predicate device comparison
Draft an ISO 14971 hazard analysis table
Q&A across your DHF and SOP library
Turn meeting notes into design-review minutes
Pricing

One-time price, installed on-site.

No per-seat fees, no usage bills. 30-day money-back pilot on every system.

Low Tier

F-18 Hornet

Professional offices, small manufacturers, and departments

Starting at$22,900one-time
Up to ~150 people
Full specs
High Tier

F-22 Raptor

Larger organizations running multiple models side by side

Starting at$59,990one-time
250+ people or heavy engineering use
Full specs

Enclave is a general-purpose AI tool, not a medical device, and is not intended for clinical decision-making.

See it in your building

Give us 30 minutes and a power outlet.

We’ll bring the server to your office, load public documents from your industry, and let your team try it on the questions they’d actually ask.

Or reach us directly: (715) 410-6587 info@enclaveservers.com
Call Book a demo