Services


Each PragmaSafe service is anchored in one of the four PISA domains — bringing structural coherence to every engagement.

Conformity Safety

AI Act Conformity

Organisations deploying high-risk AI systems under the EU AI Act face lifecycle documentation obligations they were not designed to meet.

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Architectural Safety

Safety Architecture

We define the safety concept, allocate risk to system components, and establish the safety-critical architecture before a line of code is written or a test is planned.

Coming soon

Validation Safety

Validation Strategy

We build the evidence base — structured scenario testing, dataset validation, and test sufficiency assessment — all traceable to the safety claims they must support.

Coming soon

In-Service Safety

In-Service Safety

We design and implement operational monitoring that keeps the safety case alive after deployment — field anomaly detection, safety-relevant data collection, and post-market surveillance.

AI Act Conformity

PISA Domain: Conformity Safety


The risk it addresses

Organisations deploying high-risk AI systems under the EU AI Act face lifecycle documentation obligations they were not designed to meet. Most compliance efforts produce documentation without the underlying engineering substance to support it.

The structural gap it solves

Notified bodies assess conformity. They do not architect safety. The gap between a safety engineering programme and a compliant technical file is where most organisations lose time and credibility.

What PragmaSafe delivers

  • Structured technical file preparation
  • Risk management documentation aligned to Article 15
  • Post-market monitoring plans for Article 61
  • Traceability from system architecture to regulatory requirements
  • Preparation for notified body engagement

Typical outcomes

A technical file that reflects engineering reality. A risk management record that traces to the system architecture. Confidence in notified body review.