Ketryx

Ketryx develops an AI-powered platform for product development and compliance in regulated industries. Its software connects engineering work with quality and regulatory processes, helping teams maintain traceability and produce documentation as products are developed. The company describes its mission as making regulated systems safe and reliable through technology, with a vision of products that perform without unintended harm.

The platform is designed to work with tools teams already use, rather than replace their existing development systems. Ketryx identifies Jira and GitHub among its integrations and says it can connect development activity to requirements, risks, tests, and release evidence. The company positions this approach as a way to reduce manual documentation and support continuous compliance while keeping development workflows familiar.

Ketryx serves organizations building safety-critical and regulated products. Its public materials highlight medical devices and life sciences, as well as robotics, aerospace, defense, and other sectors with demanding product assurance needs. The platform supports activities such as automated documentation, traceability, risk management, quality-system enforcement, and release readiness. Ketryx describes its medical-device offering in relation to standards and regulations including IEC 62304, ISO 14971, ISO 13485, FDA requirements, and EU MDR.

The company was co-founded in 2021 by Erez Kaminski and Jan Pöschko. Ketryx’s company history says Kaminski encountered the challenge of maintaining high assurance and documentation while leading AI and machine-learning initiatives at Amgen. The founders set out to bring modern software development practices to regulated environments, and the company began building integrations for Jira and GitHub. Its public history records early backing from MIT’s E14 Fund and Ubiquity Ventures, later investment rounds, and expansion of teams in Boston and Vienna.

Ketryx serves product development, quality, and regulatory professionals, including teams at medical-device manufacturers and other regulated-product companies. The company states that its platform is used by major medical-device manufacturers; that statement is a company-reported claim. Customer testimonials published on its site describe use cases involving connected traceability, documentation generation, risk management, and integration with existing engineering processes.

Ketryx presents itself as an engineering-led company focused on combining product velocity with safety and compliance. Its stated working principles include prioritizing meaningful outcomes, giving people autonomy and ownership, applying quality standards according to risk, learning continuously, solving difficult problems as a team, and investing in capabilities that compound over time. The company says it takes its mission seriously while maintaining a culture of transparency, discipline, and momentum.