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Secure and compliant IT infrastructure for medical device manufacturers, distributors, and service organizations. From asset tracking to regulatory compliance.
FDA 21 CFR Part 11
Electronic records compliance
ISO 13485
Medical device quality management
IEC 62443
Industrial cybersecurity
HIPAA
Patient data protection
Specialized IT solutions for the medical device industry
Comprehensive tracking and management of medical devices throughout their lifecycle.
IT infrastructure that supports FDA, CE, and other regulatory requirements.
Encrypted and secure communication channels for device data and operations.
Real-time monitoring and management of deployed medical devices.
Secure storage and management of device data and clinical information.
Connect medical devices with healthcare systems and cloud platforms.
Let's discuss how we can help you meet compliance requirements while improving operational efficiency.