Ketryx

Ketryx is a startup that provides a specialized software platform designed to streamline the development and compliance processes for medical software applications. The company operates in the medical technology (MedTech) sector, focusing on clients who develop regulated medical software, including startups and large enterprises. Ketryx's platform is particularly beneficial for companies that need to adhere to stringent regulatory standards such as FDA regulations, IEC 62304, GMP, ISO 13485, and CFR 21 Part 11.

The core offering of Ketryx is its Connected Lifecycle Management platform, which helps clients manage the entire lifecycle of their medical software products. This includes ensuring compliance with regulatory requirements, improving product quality, and accelerating time to market. The platform integrates various tools and capabilities such as traceability, documentation, Jira integration, and Software Bill of Materials (SBOM) management. These features help clients maintain compliance and manage their product development processes more efficiently.

Ketryx's business model is based on a Software-as-a-Service (SaaS) approach. Clients subscribe to the platform and pay for access to its suite of tools and services. This subscription model provides Ketryx with a steady stream of recurring revenue. Additionally, the company offers various pricing tiers to cater to different sizes of organizations, from startups to large enterprises.

In summary, Ketryx simplifies the complex process of developing and maintaining FDA-compliant medical software. By providing a comprehensive platform that integrates essential compliance and lifecycle management tools, Ketryx helps its clients reduce costs, mitigate compliance risks, and bring their products to market faster.

Keywords: MedTech, FDA compliance, lifecycle management, SaaS, medical software, regulatory standards, traceability, documentation, Jira integration, SBOM.