Structured Operational Health Programs. SLA-backed maintenance covering defect resolution, OS upgrades, performance tuning, and IEC 62304-compliant change management documentation.

PSUR and PMCF Data Aggregation Infrastructure. Tooling and processes to satisfy post-market surveillance. Complaint intake pipelines, adverse event capture, trend analysis dashboards, and CAPA support.

End-to-End Cybersecurity for Connected Devices. End-to-end security services aligned with FDA (2023) guidance, MDCG 2019-16, and IEC 81001-5-1. STRIDE threat modelling, vulnerability management, SBOM creation, and CVE monitoring.

Regulatory Change Control for FDA-Cleared Products. Continuous DHF and Technical File updates, assessment of regulatory impact for changes, and preparation for periodic notified body periodic audits.

Subscription-Priced, Compliance Evidence-as-a-Service. Proactive infrastructure monitoring, continuous QMS maintenance, SBOM monitoring, and managed cloud cost optimization for MedTech environments.

Faster Signal Detection and CVE Flagging. Surfacing anomalies in complaint data faster, drafting change-control documentation from structured inputs, and flagging CVE matches, with every consequential decision under human review.