Ketryx
AI-native compliance & regulatory platform for medical-device and life-science software

Founded

2021

Staff

130

Organization type

service provider

Region

Vienna

Cluster

LISAvienna

Topic

software for medicine

Focus R&D

development

Research area

medical engineering

Offer

IT Services

Ketryx builds an AI-native compliance and regulatory platform for medical-device and life-science software teams. It integrates with the tools engineers already use (e.g. Jira, GitLab/GitHub) to automate design controls, risk management, traceability, QMS and document generation, helping teams stay compliant with ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 11 and MDR/IVDR while releasing faster and with less manual paperwork. It supports the full lifecycle, from early development through certification and post-market surveillance, for both software-as-a-medical-device and software embedded in hardware devices.

Services:Ketryx provides an AI-native platform that automates regulatory and quality work for medical-device and life-science software teams: design controls, risk management, traceability, QMS and audit-ready documentation across ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 11 and MDR/IVDR. It integrates with the engineering tools teams already use (Jira, GitLab/GitHub) and covers the full lifecycle, from development through certification and post-market surveillance.