Built for regulated work, from day one.

We have shipped software for healthcare, life sciences and the public sector since 2014, including the cloud LIMS that validated 6M+ genetic samples for Oncologica. Opening a system to AI does not change that: the MCP gate is where permissions, approvals and logs live.

§ 01Principles

Your data stays put. Control you keep.

  • 01

    Data stays in your environment

    Systems and agents run inside your environment. No data is sold, and nothing leaves your systems of record without your rule.

  • 02

    Human-in-the-loop

    Every tool is scoped by role; sensitive actions wait for a person with full context. The agent accelerates, it does not override.

  • 03

    Full audit trail

    Every call through the gate is logged with inputs and outcome. When an auditor asks what happened and why, there is a record.

§ 02Aligned deliveryISO 13485 · ISO 27001 · IEC 62304 · SOC 2 TYPE 2

The standards we build to.

We deliver aligned to the standards your industry requires. Where a formal certification applies to your project, we scope it explicitly.

  • ISO 13485

    Medical-device quality management

  • ISO 27001

    Information security management

  • IEC 62304

    Medical-device software lifecycle

  • SOC 2 TYPE 2

    Security, availability & confidentiality

§ 03How we operate

Controls on every system and every agent.

  • Least-privilege access to the modules an agent touches, scoped per workflow and revocable.
  • Typed MCP tools: reads, writes and sensitive actions are separate scopes with explicit inputs and outputs.
  • Encryption in transit and at rest; secrets kept out of prompts and logs.
  • Guardrails and monitoring on every deployed agent, with alerting on anomalies.
  • Change control and versioning, so every update to a module or an agent is reviewable and reversible.
  • Data-processing agreements with sub-processors, and EU data residency where required.

§ 04

Open your systems to AI without the compliance risk.

Book a 30-minute scoping call: we map the workflow and the controls it needs before anything goes live.