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.
These architectural choices support control over the workflows in your deployment. Their benefits depend on configuration, integrations and operating practices. Review external connections, physical security, access and compliance responsibilities together.
Scope inference, extraction, retrieval and storage on infrastructure you control. Document and test any external connector, support channel or transfer before describing a workflow as zero-egress.
Workflows with local models, data and supporting services can continue offline. Live external email, calendars and other services need an approved connection or controlled import, with clear unavailable and pending states.
Map prompts, documents, indexes, logs and backups to their processing and storage locations. Local hosting supports control of location; access, retention and any transfers still need review.
Prepare and classify source records, preserve permissions and evaluate answers against the originals. Retrieval and model training are separate choices; agree data use and licences for each.
Compare hardware and licences alongside integration, power, administration, support, updates, evaluation and recovery. Measure cost at the required workload and quality before claiming savings.
Define who holds keys, who can administer the system and which actions need approval. Test denied requests, revoked access and audit records. Physical security, insider risk and incident response remain operational responsibilities.
Agree version selection, signed update procedures, rollback, data export and licence rights. Reassess requirements as software and obligations change; owning hardware does not remove maintenance or compliance work.
Review the requirements relevant to your organisation, jurisdiction and intended use with your responsible teams. Cloud services can be appropriate subject to applicable safeguards; on-premise deployment alone does not establish compliance or remove supplier responsibilities.
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. Scope their local processing, operator-held keys and Open Audit Record coverage for the proposed deployment. Confirm availability and any external integrations before relying on a workflow.
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.
Measure value, cost and risk on hardware you control.
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.