Snapshot 28243
Normalized text
Scripts and page chrome removed; this is what change detection compares.
Welcome to the RadiusXR, Inc. Trust Center At RadiusXR, Inc., protecting patient health information (PHI), clinical data, and patient safety is not just a compliance obligation; it is core to how we build and operate our platform and devices. As a MedTech SaaS company serving healthcare providers across the US, EU, and other international markets, we are committed to maintaining strong standards of data privacy, security, product quality, and regulatory accountability. Our security posture is underpinned by a comprehensive Information Security Management System (ISMS), continuous risk monitoring supported by automated GRC workflows and operational controls, and adherence to globally recognized frameworks. Our quality management processes also support the development and maintenance of safe, effective, and reliable products through established design controls, risk management activities, and ongoing product oversight. This includes product safety and performance testing aligned with recognized medical device standards relating to electrical safety, electromagnetic compatibility, and biocompatibility. We engage independent auditors annually to assess conformity to industry-recognized certifications and attestations. We go beyond baseline compliance by proactively identifying and mitigating risks to safeguard the integrity, confidentiality, safety, and performance of our products and services. We also maintain post-market monitoring processes to continuously assess device performance, identify potential risks, and support the timely resolution of issues where needed. This Trust Center provides transparency into our security, privacy, and quality practices so you can make informed decisions about partnering with RadiusXR, Inc. | | | | Overview Compliance Controls Subprocessors Announcements Compliance ISO/IEC 27001:2022 Certified ISO/IEC 27701 Certified SOC 2 Compliant US TX-RAMP Level 2 Certified HIPAA Compliant GDPR Compliant UK GDPR Compliant ISO 13485 (Medical Device QMS) Certified MDSAP (Medical Device QMS Audit) Certified EU MDR CE Mark Compliant FDA (United States) Compliant TGA (Australia) Compliant Health Canada Compliant COFEPRIS (Mexico) Compliant ANMAT (Argentina) Compliant ISP (Chile) Compliant INMETRO (Brazil Safety & EMC) Certified ANATEL (Brazil Wireless) Certified RCM Mark (Australia EMC) Compliant IEC 60601-1 (Electrical Safety) Compliant IEC 60601-1-2 (EMC) Compliant ISO 10993 (Biocompatibility) Compliant IEC 62366-1 (Usability) Compliant IEC 62304 (Software Lifecycle) Compliant Controls Product security Production System User Review Situational Awareness For Incidents Vulnerability Remediation Process Data security Identity Validation Termination of Employment Production Databases Access Restriction Network security Impact analysis Limit Network Connections External System Connections App security Conspicuous Link To Privacy Notice Secure system modification Approval of Changes Endpoint security Malicious Code Protection (Anti-Malware) Full Device or Container-based Encryption Endpoint Security Validation Corporate security Code of Business Conduct Organizational Structure Roles & Responsibilities Subprocessors AWS Cloud Providers United States of America Google Workspace IAM providers United States of America Mongo Atlas Datastore Providers United States of America Salesforce Sales United States of America Zendesk Helpdesk Software United States of America Twilio Others United States of America Announcements RadiusXR Successfully Completes ISO/IEC 27001:2022 Surveillance Audit Aug 18, 2026 RadiusXR has successfully completed its annual surveillance audit for ISO/IEC 27001:2022, conducted by INTERCERT. The audit confirmed the continued effectiveness of our Information Security Management System across cloud product delivery, customer and business data handling, and supporting business functions. RadiusXR sustains this standard through independent annual assessment. RadiusXR Receives DIGEMID Approval in PERU Jul 13, 2026 RadiusXR has received regulatory approval from DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), Peru's national medical device regulatory authority. RADIUS is awarded a Class II listing under Sanitary Registration No. DB10576E. This approval authorizes RadiusXR to operate within the Peruvian healthcare market. It marks a significant milestone in our South American expansion, reflecting our commitment to meeting the highest regulatory standards across every jurisdiction we serve. RadiusXR Achieves TGA Registration in Australia Apr 17, 2026 RadiusXR has achieved Therapeutic Goods Administration (TGA) registration in Australia, with the device listed on the Australian Register of Therapeutic Goods (ARTG ID: 525666) as a Class IIa medical device. This registration confirms that RadiusXR's platform meets Australia's rigorous safety, performance, and quality requirements under the Therapeutic Goods Act, enabling RadiusXR to serve Australian healthcare providers with full regulatory standing. This milestone reflects our ongoing commitment to global market access and clinical-grade regulatory compliance across every market we operate in. Create your own Trust Center | Powered by