Built for
Regulatory Excellence
AEGIS undergoes independent verification of security, privacy, and compliance controls, delivering certifications against global standards to earn your trust.
Our Certifications
AEGIS maintains comprehensive certifications to ensure compliance with global regulatory standards for medical device software and healthcare data management.
IEC 62304
Medical device software lifecycle processes standard ensuring systematic development, maintenance, and risk management for software used in medical devices.
ISO 13485
Quality management system certification specifically designed for medical device manufacturers, ensuring consistent design, development, and production processes.
ISO 27001
Information security management system certification ensuring comprehensive protection of sensitive data through systematic risk management and security controls.
MDSAP
Medical Device Single Audit Program enabling a single regulatory audit to satisfy requirements of multiple regulatory jurisdictions including FDA, Health Canada, and others.
HIPAA
Health Insurance Portability and Accountability Act compliance ensuring protection of patient health information through comprehensive privacy and security safeguards.
SOC 2 Type II
Service Organization Control audit verifying security, availability, processing integrity, confidentiality, and privacy controls over an extended period.
Comprehensive Compliance Framework
AEGIS is built on a foundation of regulatory compliance, ensuring your ACNU and SaMD programs meet the highest standards.
FDA Regulatory Compliance
Full compliance with FDA requirements for ACNU programs and SaMD submissions.
- 21 CFR Part 11 electronic records and signatures
- ACNU automated failure reporting
- IEC 62304 software lifecycle processes
- ISO 14971 risk management
- Design history file (DHF) generation
Data Security & Privacy
Enterprise-grade security protecting sensitive patient and clinical data.
- HIPAA-aligned data protection
- GDPR compliance for EU operations
- End-to-end encryption (in transit & at rest)
- Role-based access controls (RBAC)
- 10-year immutable audit trails
Quality Management System
ISO 13485-certified QMS ensuring consistent quality across all processes.
- Document control and version management
- Change control procedures
- Corrective and preventive actions (CAPA)
- Supplier and vendor management
- Continuous improvement processes
Global Regulatory Alignment
Multi-jurisdiction compliance supporting worldwide deployments.
- EU MDR (Medical Device Regulation)
- MHRA (UK regulatory compliance)
- Health Canada requirements
- PMDA (Japan) alignment
- MDSAP multi-jurisdiction support
Secure Infrastructure
AEGIS runs on enterprise-grade, healthcare-compliant cloud infrastructure with multiple layers of security and redundancy.
Data Residency
Regional data centers ensuring compliance with local data sovereignty requirements and low-latency access.
Encryption
AES-256 encryption at rest, TLS 1.3 in transit, with hardware security modules (HSM) for key management.
Disaster Recovery
Multi-region backup and replication with automated failover ensuring 99.99% uptime and business continuity.