Medical Devices
Medical-device manufacturers carry ISO 13485 quality obligations, FDA 21 CFR Part 11 electronic-records duties and lasting product-liability exposure, all of which turn calibration and device-log data into evidence that must be controlled, traceable and sandboxed. They want to interrogate machine logs, calibration records and complaint data at scale without handing that material to a third-party cloud, because a breach or an uncontrolled transfer becomes a regulatory and litigation problem in its own right. Public AI services are barred precisely because they put the most sensitive design-history and traceability records outside the firewall, beyond the manufacturer's own controls. Mickai runs the entire AI capability on hardware the manufacturer owns, under keys it holds, so compliant quality auditing of machine logs happens locally and the data never leaves the building.
Medical-device manufacturers and their quality, regulatory and operations leaders.
ISO 13485, FDA 21 CFR Part 11 and product-liability exposure mean calibration and device data must stay sandboxed, so cloud AI is barred from the records most worth analysing.
Mickai runs compliant quality auditing of machine logs and calibration data locally, on hardware the manufacturer owns and under keys it holds.
Non-compliance is flagged before audits, inside the firewall, with no third party ever seeing the underlying device records.
Five advantages hold across every sector, and they are architectural, not promotional. The third-party cloud-exposure vector is removed; your own physical, insider, and compliance controls remain yours.
The data never leaves your hardware, so no third party and no cloud-provider employee ever sees it. What happens in the server room stays in the server room.
You own the compute and the capability, so the system runs independent of the internet and of any cloud vendor's pricing, terms, or availability.
The data never crosses a geographical or digital border because it never leaves the building, which removes the cross-border-transfer and third-party-processing friction of UK GDPR, Schrems II, and the sector rules. You keep your own obligations.
Fine-tune and run retrieval on your deepest archives to build a hyper-customised co-pilot, with no risk of your proprietary edge training a public model or leaking.
After the hardware and licence, queries cost essentially electricity. A capital asset you own and depreciate, instead of volatile per-token cloud bills.
There is no third-party cloud path, so no competitor and no vendor insider can scrape, intercept, or subpoena your prompts or your fine-tuned weights from the internet. The trust vault is closed by architecture.
You own the software snapshot on your own hardware, so a change to a cloud vendor's terms, a model deprecation, or an outage cannot reach you. The system stays predictable and auditable on-premise as the rules evolve.
The specific rules that bar mainstream cloud AI from this sector's regulated data. Each one demands a named, auditable perimeter the operator controls, which a shared multi-tenant cloud cannot give.
The kind of organisation this serves, named illustratively from public information to characterise the market. These are target profiles, not customers: Mickai has no relationship, engagement, trial, or endorsement with any of them.
The enterprise studios that lead in this sector, drawn from the eighteen that sit on the one sovereign substrate. Each runs on hardware the organisation owns, under one set of operator-held keys, writing to one Open Audit Record.
Audit
Audit studio that reads machine logs, calibration records and the design-history file locally, building the evidence trail ISO 13485 and Part 11 demand without exporting any of it.
Predictive Maintenance and OT
Predictive Maintenance and OT studio that ingests calibration and equipment telemetry to flag drift and out-of-tolerance conditions before they reach a finished device.
Compliance and Regulator Mode
Compliance and Regulator Mode studio that maps machine-log findings against ISO 13485, Part 11 and MDR controls and prepares a defensible record for inspection.
Executive BI
Executive BI studio that surfaces quality and non-conformance trends across lines and sites so leadership sees liability exposure without data leaving the firewall.
Contract Review and Legal-Ops
Contract Review and Legal-Ops studio that ties supplier, calibration-service and quality agreements to the obligations the device records have to satisfy.
See all eighteen on the sovereign services catalogue.
Device makers face tightening enforcement under MDR and sustained FDA scrutiny while AI-driven quality analytics remain mostly cloud-bound and therefore off-limits for their most sensitive records, leaving a clear gap for an in-house capability. The buyers are quality, regulatory and operations leaders who already hold the data and need to mine it without surrendering control of it.
Money won, money saved, risk removed, on hardware you own.
Non-compliance and out-of-tolerance conditions are flagged inside the firewall before an audit or a field event, which shortens inspection readiness, reduces the cost and disruption of findings and recalls, and lowers product-liability exposure. Running the analytics on owned hardware removes the third-party cloud-exposure vector and displaces recurring cloud-compute and data-egress spend, while physical and insider controls remain the manufacturer's own.
Map the sovereign stack to your medical devices estate.
Briefings are for organisations weighing a sovereign, on-premises deployment. Tell us about your estate and we will walk the pack, the regulatory crosswalk, and the deployment that fits your estate.