Tier 1 & Tier 2 Support
Comprehensive 24/7 technical surveillance and highly specialized resolution services designed for FDA-regulated MedTech products.
Regulatory Compliance Tool Identification
Identify the T1 & T2 tools for customers/partners which demonstrably satisfy critical regulations including:
- ISO 13485 (Medical Devices Quality Management)
- 21 CFR Part 11 (FDA Electronic Records; Electronic Signatures)
- 21 CFR Part 820 (FDA Quality Management System Regulation - QMSR)
- IEC 62304 (Software Lifecycle Processes)
24 x 7 Monitoring
Uninterrupted, 24x7 monitoring of the functional operational health of the clinical deployment.
Learn moreAI-Driven Health Alarms
Implementation help and generation of automated, AI-based health check alarms to detect anomalies before humans do.
Learn moreSLA Analysis & Troubleshooting
Comprehensive T1 & T2 procedural analysis of reported customer queries and decisive action taking to satisfy, and exceed, SLA minimum contracts.
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