Documentation
SDLC documentation for your 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.
us. It takes time away from
our developers coding.
We don’t have the checks and
balances we want to prevent
process deviation.
balances we want to prevent
process deviation.
We had 55% of our team
working for two months on
document generation alone.
working for two months on
document generation alone.
I need an easy way to know
where we are missing
things.
where we are missing
things.
Ketryx AI Agents 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.
Capabilities
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
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
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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.
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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
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Ketryx automatically compiles all requirements, design inputs, outputs, and tests into a configurable design history file (DHF).
Easily configure your templates once and produce them endlessly.
Automatically generate a submission-ready DHF 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
Single source of truth: Medical device document control software
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 automatically captures each change in any record so you can easily see what changed between versions
Ketryx makes it easy to create the documentation necessary for patch releases, full releases, and versioning
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