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What is Ketryx?
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“AI-Driven Traceability and Compliance Enhance Software as a Medical Device Platforms”
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Company Description
Ketryx is an AI-native compliance platform that transforms how life-science teams build, validate, and release products. The platform connects requirements, risks, tests, code, and changes to maintain end-to-end traceability and produce audit-ready documentation. Ketryx interoperates with tools such as Jira, GitHub, and Polarion to automate documentation, support validation, and manage evidence within existing workflows. Its AI-assisted agents help identify gaps and assemble validation materials to support consistent, documented compliance practices across regulated development.
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The AI-driven document creation features perform beyond expectations. The flexibility to pull information elements from the source of truth (code, CI/CD tools, test frameworks, Jira) so that it can be easily leveraged in technical documentation is exactly what is needed to get safe and effective medical products to market faster. Traceability across multiple items (requirements, tests, risks, controls) is normally very time consuming and error-prone work. This feature alone saves time as well as potential compliance errors. Lastly, AI Agents provide a new-found level of efficiency by removing some of the most burdensome and monotonous work. Compliance and traceability issues that may go unnoticed until crunch time (e.g. the day before release) are identified well in advance, freeing up the quality and regulatory teams to focus on more value-added work.
We use this product throughout our org to handle releases which helps a lot in everything being uniform Multi layer approval needed to make sure smooth process Great UI
Options for different document output formats still have a ways to go. Ideally, the system should be able to create documents in formats other than MS Word (e.g. Google docs, sheets, Confluence pages). SBOM and vulnerability management features need to scale to larger enterprise organization levels.
Sometimes transition of state for uncontrolled items is messed up Due to dependence on JIRA uncontrolled items pop up Can be better with customer support
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Ketryx Reviews and Ratings
- Engineering Manager10B+ USDHealthcare and BiotechReview Source
AI-Driven Traceability and Compliance Enhance Software as a Medical Device Platforms
The team at Ketryx truly understands modern software development and FDA regulatory compliance in the age of AI. This deep knowledge has been thoughtfully applied to create a highly usable and flexible software platform desperately needed by innovative companies pushing the boundaries of what is possible with software as a medical device (SaMD). The team is a pleasure to work with and the product is nothing short of amazing. - Engineer1B-10B USDHealthcare and BiotechReview Source
Multi-Layer Approval System Supports Uniform Release Management Across Organization
Helps maintain releases and ensures smooth integration with JIRA