About
Ketryx is a subscription-based SaaS platform for medical device software compliance and application lifecycle management (ALM). It enables teams to generate FDA-compliant SBOMs in minutes via scanning or SPDX import and is built around the Ketryx Compliance Framework. The product explicitly targets regulatory and quality standards including IEC 62304, GMP, ISO 13485, EU MDR, and CFR 21 Part 820/11. The site highlights “Agentic AI for FDA Compliance.” Ketryx is sold as monthly, annual, and multi-year subscriptions with multiple options based on company size, stage, and products needed. The vendor states validation evidence and documentation are provided upon request and asks buyers to contact sales to learn more.
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