Secure, Compliant, and Scalable Cloud for Class III Connected Devices
Matrix Connect's secure and compliant cloud platform powers life-saving Class III devices, ensuring near-real-time data access, regulatory readiness, and seamless scalability.
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The challenge
Connecting Class III devices to the cloud without compromising safety or compliance
Class III medical devices — including implantable cardiac devices, neurostimulators, and LVADs — operate at the highest risk level. Connecting them to the cloud introduces a new layer of complexity: manufacturers must ensure near-real-time data transmission, protect sensitive patient data, and maintain compliance with FDA, HIPAA, GDPR, and HITRUST requirements simultaneously. Without the right infrastructure, teams face:
- Security vulnerabilities:Transmitting sensitive patient data from implantable or life-sustaining devices requires military-grade encryption and certified protocols — any gap can expose both patients and manufacturers to critical risk.
- Regulatory complexity:Meeting overlapping requirements from FDA, HIPAA, GDPR, and HITRUST across global markets is time-consuming and error-prone without a purpose-built compliance backbone.
- Reliability pressure:For life-sustaining devices, downtime is not an option. Generic cloud platforms aren't designed for the high-availability demands of Class III connected devices.
- Slow time to market:Building secure, compliant cloud connectivity from scratch diverts engineering resources from core device innovation and delays regulatory submissions.
Our solution
A cloud platform purpose-built for the most critical medical devices
Matrix Connect provides a secure, regulation-ready cloud infrastructure specifically designed for Class III medical device manufacturers. Rather than adapting general-purpose cloud tools to meet medical-grade requirements, Matrix Connect puts compliance and security at the center of its architecture — so your team can focus on building life-saving devices, not infrastructure.
- Medical-grade security from day one:HITRUST-certified protocols and end-to-end encryption protect sensitive patient data at every stage from device transmission to cloud storage without requiring manufacturers to build it themselves.
- Regulatory compliance across global markets:FDA, HIPAA, and GDPR requirements are embedded in the platform, covering design, cybersecurity, and privacy standards across every jurisdiction your device operates in.
- High availability for life-sustaining technologies:Intelligent failover and redundancy mechanisms ensure the near-real-time data flow that Class III devices demand with no tolerance for downtime.
- Proven in production:Matrix Connect is actively supporting Class III implantable devices including LVADs, neurostimulators, and cardiac monitoring solutions giving manufacturers a trusted, battle-tested foundation to build on.
Core Features
Near-Real-Time Connectivity for Critical Devices
Reliable, secure data flow for life-sustaining technologies. Continuous near-real-time data transmission enables remote monitoring and management of Class III devices without compromising security or regulatory compliance. Intelligent failover and redundancy mechanisms ensure high availability for mission-critical devices, while advanced cloud connectivity supports remote diagnostics, over-the-air updates, and predictive maintenance to keep devices performing at their best.
HITRUST-Certified Security
End-to-end data protection from device to cloud. HITRUST-certified security protocols safeguard patient data at every stage — from transmission to cloud storage and analytics. Full compliance with both HIPAA and GDPR ensures that connected devices meet the strictest global regulatory requirements without adding complexity for manufacturers or their engineering teams.
Proven Support for Class III Implantable Devices
Already trusted by leading manufacturers of high-risk medical technologies. Matrix Connect is actively supporting Class III implantable and life-sustaining devices in production environments, including LVADs, neurostimulators, and cardiovascular monitoring solutions. Integration with FDA-cleared algorithms — such as B-Secur's cardiac monitoring technology — provides enhanced clinical insights and demonstrates the platform's ability to meet the most demanding device requirements.
Multi-Device Compatibility
Scalable connectivity across a wide range of Class III device categories. Designed to support cardiac implants, drug delivery systems, ventilatory support devices, and more, Matrix Connect handles the full diversity of Class III device types within a single, unified platform. Whether you're connecting one device type or building a portfolio of connected products, the platform scales to meet your needs.
Global Compliance Coverage
Stay ahead of regulatory requirements across every market you operate in. Matrix Connect customers sell their devices across all 6 continents and multiple regulatory jurisdictions. The platform is built to keep pace with evolving global compliance requirements — covering design and development, cybersecurity, and data privacy standards so your team doesn't have to track regulatory changes market by market.
Every Certification You Need For Worldwide Success
Global Reach
Our customers sell their devices across all 6 continents and in multiple jurisdictions. Matrix Connect stays ahead of changing global compliance needs so you don't have to.
Regulatory & Industry Standards Covered
Achieve compliance to regulatory and industry standards across design & development, security, and privacy arenas with a cloud connectivity solution that puts compliance at the center of our product development.
Hear from our customers
With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”
François Audéon, Chief Technology Officer
