Sold by: Ketryx
Deployed on AWS
AWS Free Tier
Build FDA-compliant software | Automate audit-grade documentation and traceability. Agile SAFe, Part 11, 13485, 62304, 14971, QMS
4.8
Overview
Ketryx is an AI-native compliance platform that transforms how life science teams build, validate, and release products. Trusted by three of the world's top five medical device manufacturers, Ketryx's AI Agents interoperate with existing tools like Jira, GitHub, and Polarion to automate documentation, create end-to-end traceability, and accelerate release cycles-without disrupting existing workflows. AI Agents reduce manual work by up to 90% and close compliance gaps, helping teams deliver safer, higher-quality products faster.
Highlights
- AI across your DevTools: Ketryx AI Agents interoperate with your DevTools like Jira, GitHub, GitLab, and AWS-analyzing work as it happens and capturing compliance context automatically. Developers stay in flow while AI handles the regulatory lift.
- AI-driven QMS enforcement: Ketryx AI Agents act as quality enforcers across all connected systems. They coach developers in real time, flag deviations, and automatically enforce QMS processes directly in your preferred DevTools.
- AI-powered traceability: Ketryx generates a living traceability matrix-continuously mapping requirements, risks, and tests. AI Agents detect gaps, propose missing links, and suggest risk controls before auditors ever see the file.
Details
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Delivery method
Deployed on AWS
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Pricing
This product is available free of charge. Free subscriptions have no end date and may be canceled any time.
Additional AWS infrastructure costs may apply. Use the AWS Pricing Calculator to estimate your infrastructure costs.
Dimensions summary
Ketryx lists a single pricing option on AWS Marketplace: a Free tier. You pay nothing to use it. There are no paid tiers, usage add-ons, or instance sizes to choose from in this listing. The Free tier gives you access to Ketryx as described at the vendor's pricing page. Because only one option exists, there is no scaling logic or tier comparison to weigh. You can start using the product without a commitment term or quantity selection.
Top-of-mind questions for buyers
The Free tier gives you access to the connected lifecycle management platform for regulated software. You can generate technical documentation, build a traceability matrix, and connect existing developer and quality tools. It supports compliance workflows across the software development lifecycle, from planning through post-market surveillance.
Yes. Ketryx runs as a hosted service you access through your organization's workspace. You log in online and connect your existing development and quality tools. There is no instance size, hardware provisioning, or infrastructure to manage on your side under this listing.
No. The Free tier carries no commitment term and no quantity selection. You pay nothing and can start without choosing a contract length. It is a single option with no usage add-ons or tiers to configure within this listing.
www.ketryx.com+1
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All fees are non-refundable and non-cancellable except as required by law.
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Delivery details
Software as a Service (SaaS)
SaaS delivers cloud-based software applications directly to customers over the internet. You can access these applications through a subscription model. You will pay recurring monthly usage fees through your AWS bill, while AWS handles deployment and infrastructure management, ensuring scalability, reliability, and seamless integration with other AWS services.
Resources
Vendor resources
Support
Vendor support
Email support services are available from Monday to Friday.
support@ketryx.com
AWS infrastructure support
AWS Support is a one-on-one, fast-response support channel that is staffed 24x7x365 with experienced and technical support engineers. The service helps customers of all sizes and technical abilities to successfully utilize the products and features provided by Amazon Web Services.
Customer reviews
Yonatan V.
Excellent time saving ALM for medical device software
Reviewed on May 27, 2026
Review provided by G2
What do you like best about the product?
A very convenient, efficient, time saving and well documented application lifecycle management system for development of software in and as medical devices.
What do you dislike about the product?
The configurations require JSON format editing
What problems is the product solving and how is that benefiting you?
Manage the application development, from the requirements to the verification and validation, with full traceability and revision control
Aaron B.
Fantastic tool and great support
Reviewed on Feb 05, 2025
Review provided by G2
What do you like best about the product?
Ketryx has been integral in our ability to develop and release compliant software in an integrated fashion. It connects the tools our team is already using and comfortable with. Even more important is the level or active support the Ketryx team provides both at project initiation and throughout our journey.
What do you dislike about the product?
It is a newer tool and many features are still being built out.
What problems is the product solving and how is that benefiting you?
Ketryx has been integral in our ability to develop and release compliant software in an integrated fashion. It connects the tools our team is already using and comfortable with. Even most important is the level or active support the Ketryx team provides both at project initiation and throughout our journey.