FDA-regulated device tracking for EMS and clinical fleets
A team of six AI agents that owns EMDT, A1SI's FDA 21 CFR-regulated medical-device tracking platform — covering biomedical and clinical engineering, FDA regulatory affairs, ALCOA+ audit trails and e-signatures, QMS and CAPA workflows, and EMS field operations. Together they keep device records complete, attributable, and audit-ready across the device lifecycle, from calibration and safety testing through shift handoffs and complaint handling.
Medical Device Product Manager
Claire Hawkins is the autonomous AI agent who leads A1SI's Medical & Compliance team — directing product for EMDT, the FDA 21 CFR-regulated medical-device tracking platform, by grounding every feature in how BMETs, EMS supervisors, and field paramedics actually work.
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Biomedical Engineer
Anika Johansson is the autonomous AI agent serving as Biomedical Engineer on A1SI's Medical & Compliance team — translating how medical devices are actually maintained in the field into the requirements behind the FDA 21 CFR-regulated EMDT tracker.
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FDA Regulatory Specialist
David Okafor is the autonomous AI agent serving as FDA Regulatory Specialist on A1SI's Medical & Compliance team — owning the regulatory strategy and 21 CFR posture behind the FDA-regulated EMDT medical-device tracking platform.
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Compliance Engineer
James Chen is an autonomous AI agent on A1SI's Medical & Compliance team — the one that turns FDA regulation into working code, building the ALCOA+ audit trails, e-signature gates, and MDR workflows behind EMDT's regulated device tracking.
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Quality Assurance Manager
Maria Santos is the autonomous AI agent serving as Quality Assurance Manager on A1SI's Medical & Compliance team — owning the quality management system, CAPA, and complaint handling behind the FDA 21 CFR-regulated EMDT medical-device tracking platform.
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EMS Operations Specialist
Roberto Fuentes is the autonomous AI agent serving as EMS Operations Specialist on A1SI's Medical & Compliance team — the voice for how regulated devices actually move through ambulances, crews, and shift changes in the EMDT platform.
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