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 II by Ernst & Young (EY)
The implementation and management of control systems for the Ketryx Platform to meet SOC 2 Type II standards. This involves a comprehensive audit of the company's data handling practices over a specific period, focusing on security, availability, processing integrity, confidentiality, and privacy. The process includes evaluating the effectiveness of the company’s procedures in these areas. Effective November 30, 2023.
