SDLC documentation for your regulated medical device — powered by AI

Produce audit-ready and submission-ready documentation through the tools your developers are already using.

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Manual software development lifecycle documentation is risky, costly, and time-consuming

MedTech companies tell us:

• Documentation is killing us. It takes time away from our developers coding.
• We had 55% of our team working for two months on document generation alone.
• We don’t have the checks and balances we want to prevent process deviation.
• I need an easy way to know where we are missing things.

Ketryx AI automatically document and check your work

Ketryx generates Part 11-compliant audit trails directly from your team’s favorite DevTools, like Jira and GitHub, creating evidence while your developers are coding.

Use AI to reduce your medical device SDLC documentation cycle from 3 months to 3 days

Get all the documentation you need for FDA, MDR, and other regulatory bodies – faster.

Traceability

Automatic Part 11-compliant audit trail

Connect Ketryx to any supported development tool.

Ketryx extracts the relevant text and metadata from each item.
Ketryx creates a Part 11-compliant record and audit trail of all changes for the item.

Preferred Dev Tools

Medical device document control software with Part 11-compliant signatures in Jira

Developers don’t have to leave their development tools.
Review and approve items in Jira by your designated approvers.
Provide Part 11-compliant signatures using features such as multi-factor authentication and biometric scanning.

Software Bill of Materials (SBOM) Generation

Ketryx creates a single consolidated view of your open-source supply chain directly from your source code.
Comply with regulations around COTS, SOUP, and Off-the-shelf Software (OTS), and Open Source, like IEC 62304/GAMP 5 and CFR 21 part 11.

Configurable Audit-Ready and Submission-Ready Design and Development File

Ketryx automatically compiles all requirements, design inputs, outputs, and tests into a configurable Design and Development File.
Easily configure your templates once and produce them endlessly.
Automatically generate a submission-ready Design and Development File that can scale to systems of systems.
Create configurable risk tables, Excel files, PDFs, Word files, and any other piece of evidence you need to generate for regulatory purposes.

Benefits of Ketryx's SDLC documentation software

AI-generated documentation means no more manual copy-pasting

Seamless real-time alignment between documentation and DevTools reduces non-compliance risk.

• Trace matrix is updated instantly whenever a change is made in any development tool.
• All software documentation stays up to date: SRS, SDD, risk management, software testing, unresolved anomalies, SBOM.

More time coding, less time documenting

Ketryx logs updates to your records automatically, providing a clear comparison of modifications between any two versions.

Ketryx makes it easy to create the documentation necessary for patch releases, full releases, and versioning.

Are You Building Medical Software?

Get started building software in minutes, not months.