Certifications
International Standards
IEC 62304:2006 by UL Solutions
The development and control of Ketryx Platform software for building medical products to IEC 62304. Incorporating software development planning including identification and management of software hazards, software development planning, requirements analysis, architectural design, unit implementation and verification, integration and integration testing, system testing, software release, configuration management, and problem resolution from conception to decommission of the software. Effective November 30, 2023.
ISO 13485:2016 by UL Solutions
The design, manufacturing, and development of software as a service platform that manages medical device Total Product Lifecycle artifacts. Effective November 30, 2023.
ISO 14971:2019 by UL Solutions
The identification of hazards, estimation and evaluation of the risk, control of the risk and monitoring of the effectiveness of control for Ketryx Platform software. Effective November 30, 2023.
SOC
SOC 2 Type 2 by Sensiba
The implementation and management of control systems for the Ketryx Platform to meet SOC 2 Type 2 standards. Ketryx undergoes an annual SOC 2 Type 2 examination assessed against the Security, Availability, and Confidentiality Trust Services Criteria. The examination covers the design and operating effectiveness of controls for the Ketryx Platform, including data handling practices and procedures. Current audit period: April 1, 2025 – March 31, 2026. SOC 2 Type 2 compliant since 2023.
HIPAA Compliance
Health Insurance Portability and Accountability Act
Ketryx is designed in accordance with HIPAA regulations, ensuring that protected health information (PHI) is handled with the highest standards of security and privacy.
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