Security Compliance Healthcare Solutions

Core Privacy & Infrastructure Pillars

Enterprise-Grade Cloud Security

Our flagship diagnostic environment is hosted via a strategic infrastructure partnership with Nuvollo Cloud. Data routing and storage utilize tier-3 data center protocols backed by SOC 2 Type II and ISO 27001 physical and network security compliance certifications.

Patient Data Privacy First

We treat Patient Health Information (PHI) with absolute security. All automated data transmission, analysis, and storage pipelines are engineered to fully comply with HIPAA (United States) and PIPEDA (Canada) end-to-end data encryption protocols.

The Aegis Regulatory Roadmap

Data Infrastructure: Fully Active Status

Implementation of secure, low-latency global cloud routing via Nuvollo. Data separation, audit logging, and automated, strict token-based authentication workflows are fully live for all active clinical evaluation systems.

Health Canada MDEL: In Progress/Strategy Phase

Preparation of our operational Standard Operating Procedures (SOPs) for distribution tracking, systematic quality logs, and mandatory problem reporting to secure our Medical Device Establishment Licence (MDEL).

FDA 510(k) Pre-Submission: Scheduled Alignment

Compilation of our Software-as-a-Medical-Device (SaMD) documentation core. This phase initiates formal FDA 510(k) Pre-Submission dialogues to lock in clinical validation protocols directly with reviewers prior to broad commercial deployment.

Framework Notice & Intended Use

The Aegis Sleep Tool is engineered in strict structural alignment with international consensus guidelines for automated healthcare software.

Regulatory Notice: The platform is currently restricted exclusively to clinical validation, pilot metrics evaluation, and investigational research partnerships. It is not currently offered for independent commercial diagnostic distribution or autonomous clinical decision-making pending final MDEL issuance and FDA 510(k) clearance notifications.

Trust, Security & Regulatory Governance