Ketryx

Ketryx provides compliance software and Application Lifecycle Management (ALM) designed for regulated medical device and healthcare software teams, focused on FDA, EU MDR, and ISO requirements. Its Compliance Framework and tooling are built for standards like IEC 62304, GMP, ISO 13485 and 21 CFR Part 820/11 to help teams deliver compliant software up to three times faster. Ketryx centralizes ALM tasks—requirements, risk management, traceability and audit‑ready documentation—so medtech companies can streamline quality processes and regulatory submissions.