Ketryx

Ketryx says it entered Stage 2 after building a repeatable product for enterprise companies; an additional $14 million in funding will support scaling operations and extending its platform to medical device and SaMD manufacturers globally.

The start-up Ketryx offers AI-powered software for medical companies. New jobs are expected to be created in Vienna.

New FDA warning letters for medical devices, medical device software, and other regulated software processes illustrates the FDA's new approach to submissions and audits with new 2023 FDA guidances.

Jira, Atlassian’s product management software, cannot ensure 21 CFR Part 11 compliance on its own and requires proper management with specific plugins or external software. The page also discusses compliance pitfalls.

The page features stories from and about Ketryx.

The company is looking to fill various roles to expand its team.

The company offers software tooling for building and maintaining FDA-regulated software infrastructure, designed for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11.

Ketryx offers compliance and ALM software through its Compliance Framework, which is described as enabling work 3x faster and is built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11.

Ketryx Corporation’s Privacy Policy applies to personal information collected through its products, services, and website.

The Terms of Service govern the Customer’s access to and use of the Ketryx Platform and associated products and services, as well as the use of Ketryx’s Offerings.

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