Felix Schaller

Founding and developing XIXUM, a formal‑semantic engine concept that transforms natural language and policy inputs into ma‑ chine‑verifiable architectures. The platform targets high‑assurance domains where neural AI alone cannot meet certification or auditability requirements.

• • Developing the core architecture combining neural perception with formal, deductive reasoning to produce traceable and au‑ ditable AI behavior

• • Designing the platform foundation for automated compliance reasoning and safety‑case generation in regulated domains

• • Building IP and technical foundation for a "Safety‑by‑Design" approach to AI engineering

Independent advisory and hands‑on engineering for clients in regulated, safety‑critical, and AI‑driven software environments. Engagements span interim leadership, fractional architect roles, and project‑based deliverables. Service areas:

• • AI Systems & Backend Architecture: structured AI pipelines, NLP‑driven transformation of unstructured inputs into verifiable models, backend APIs focused on traceability and reliability Software Safety Model‑Based Engineering: Selected 2025 – Present): Regulatory and software compliance advisory for cloud‑based PBPK modeling platforms supporting Model‑Informed Drug Development (MIDD). Developed FDA / EMA‑aligned regulatory roadmap, defined GAMP 5 risk‑based validation strategy for cloud‑deployed simulation environments, and advised on ALCOA+ data integrity for simulation outputs entering regulatory submissions.

Led the development of process methods, new inhouse tools, automation processes and validation frameworks for safety‑critical and high‑reliability environments.

• • Built model‑grounded verification and validation frameworks for complex software systems in automotive and aerospace

• • Developed model‑based approaches for traceability, testing, and certification workflows

• • Contributed to autonomy‑related perception and localization validation (Camera / LiDAR) in regulated environments

• • Implemented tooling and engineering workflows improving software reliability, auditability, and system robustness

• • Supported risk analysis, system evaluation, and real‑world deployment assessment for complex engineering systems