The Algorithmic Patient
Synthetic Clinical Agents and the Future of Regulatory Verification in Life Sciences
Executive Summary
The medical software industry faces a critical "Human Factors Bottleneck." While software development velocity has accelerated through Agile methodologies, the regulatory framework governing patient safety—specifically IEC 62366 Human Factors Engineering—remains tethered to analog, manual validation paradigms.
Sigil AI resolves this temporal mismatch by deploying Synthetic Clinical Agents. Unlike generic Large Language Models (LLMs) which optimize for competence, our agents are architected to mimic specific human limitations—cognitive load, distraction, visual impairment, and fatigue.
This platform provides an "Always-On Patient Safety Sandbox," allowing engineering teams to run thousands of simulated formative tests overnight. We do not replace the final FDA "Summative" exam; we provide the analytical certainty required to pass it.
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Includes Detailed Methodology On:
- Cognitive Architecture: Modeling working memory decay and distraction.
- Biomechanical Validity: Application of Fitts' Law for tremor simulation.
- Regulatory Mapping: Linking simulation logs to ISO 14971 Risk Management files.
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