Dxzio
Architecture review

CAPABILITIES · MEDTECH & PHARMA

Regulatory documentation that Swissmedic and the Notified Body accept.

Your Class IIa or Class III submission sits with the Notified Body, your pharmacovigilance pipeline is already running, and the next MDR surveillance is already scheduled. We deliver the substrate on which the agentic pipeline for exactly these documentation and signal tasks runs — without retroactively introducing CLOUD Act problems.

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The typical client

Swiss or EU-active MedTech manufacturers with MDR obligations (EU 2017/745) under Swissmedic supervision. Pharma manufacturers with pharmacovigilance obligations (EMA / Swissmedic). Hospital operators with EPR connection and FADP data flows.

Reproducible model evaluation

A model decision from 2026-04-22 classifying an adverse event can still be recomputed in 2031 with the identical model artifact, the same input and the same policy state. That is not "AI audit trailing" marketing — it is a prerequisite for MDR Art. 83 (post-market surveillance).

Data-flow cards as CI artifacts

Every pipeline ships its data card (data categories, processing purpose, storage location, retention period, legal basis under FADP / GDPR). The card is checked in the PR diff — a PR that changes data flows without updating the card fails.

Air-gapped inference

Clinical models run in dedicated inference clusters on EU hardware. No telemetry to model vendors. No requests to US-incorporated entities.

Audit chain for GxP requirements

Every agentic decision in a GxP-relevant pipeline (pharmacovigilance, clinical trial, regulatory submission) is Ed25519-signed and tamper-evident. Compliant with the ALCOA principle without a separate audit-trail system.

Evidence from practice

A MedTech engagement example will follow — with the customer's approval. In the meantime: architecture sketches submitted to Swissmedic in Q1 2026, feedback loop ongoing.

What we do not do

We are not a clinical validation studio. We do not provide Notified Body relationships. We do not deliver software classification per MDR Annex VIII — that is your regulatory affairs team's job. We deliver the substrate on which those activities can happen reproducibly and tamper-evidently.