Regulatory depth and standards fluency across AI-enabled, autonomous, and safety-critical domains.
Functional safety for road vehicles. E/E system architecture, ASIL decomposition, safety case structure.
Safety of machinery. Performance level assessment, safety function design.
Medical device software lifecycle. Classification, configuration management, safety-critical process compliance.
Safety of the intended functionality. Insufficiency and triggering conditions. Scenario-based testing approaches.
AI management systems. Risk-based governance for organisations developing or deploying AI.
High-risk AI system obligations. Conformity assessment, technical documentation, post-market monitoring.
Safe coding guidelines for safety-critical software. Standards development and application.
Machinery Regulation, MDR integration, Essential Health & Safety Requirements.
PragmaSafe was founded by engineers who have worked in autonomy, standards development, and regulated product deployment. Our experience is applied — not academic.
We have written standards, shipped products, and defended technical files. When we advise on conformity, we understand what a notified body is looking for, because we have been on the other side of that process.
