Cloud Connectivity, Compliance, and Security simplified.
Focus on pushing the boundaries of medical innovation while we take care of your compliance and security needs by connecting your medical device to the cloud.
For taking a demo with our team.
The challenge
Compliance shouldn't be a barrier to cloud connectivity
For medical device companies, connecting devices to the cloud means navigating a complex web of regulatory standards, data privacy laws, and cybersecurity requirements — across multiple jurisdictions simultaneously. Building and maintaining compliant cloud infrastructure from scratch requires significant expertise, time, and ongoing investment that most teams can't afford.
- Multiple standards to satisfy:Meeting HIPAA, GDPR, HITRUST, ISO 13485, IEC 62304, and other requirements simultaneously is a major burden for engineering and regulatory teams.
- Data privacy across regions:Protecting patient data in compliance with US and EU regulations requires different frameworks that must be maintained in parallel.
- Ongoing compliance maintenance:Standards evolve — and keeping your infrastructure current with changing requirements adds continuous overhead to your team.
Our solution
Built-in compliance so you don't have to build it yourself
Matrix Connect is a cloud connectivity platform built from the ground up with compliance at its core. Rather than retrofitting security and regulatory controls onto existing infrastructure, every layer of Matrix Connect is designed to meet the most stringent global standards so your team can focus on innovation, not infrastructure.
- Deploy with confidenceknowing your cloud connectivity already meets global regulatory requirements.
- Protect patient datawith enterprise-grade security controls across all stages of handling and transmission.
- Stay ahead of changing standardsMatrix Connect maintains compliance so you don't have to.
Core Features
Every certification you need for worldwide success.
HITRUST CSF r2 Certified
Matrix Connect meets the HITRUST CSF r2 standard — the most widely recognized framework for healthcare cybersecurity. This certification covers controls from ISO 27001, SOC 2, HIPAA, and other security and privacy standards, ensuring your data is protected with industry-leading practices.
ISO 13485:2016 Certified
The Matrix Connect platform is developed and operated under a robust ISO 13485:2016 certified quality management system — with development processes compliant with IEC 62304 and ISO 14971.
HIPAA Compliant
Matrix Connect adheres to HIPAA regulations, ensuring all personal health information is handled with the highest standards of privacy and security — across all stages of data handling and transmission.
GDPR Compliant
Matrix Connect complies with the General Data Protection Regulation (GDPR), ensuring personal data within the EU and UK is handled with full transparency, fairness, and accountability whether stored, transmitted, or processed.
Global Regulatory Coverage
Our customers have successfully received clearance and approval from the US FDA, CE Mark, EU MDR, IVDR, Health Canada, Australian TGA, and more selling their devices across all 6 continents with confidence.
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
