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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.

[See sample documentation](https://23261793.fs1.hubspotusercontent-na1.net/hubfs/23261793/Sample%20SRS.pdf)

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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 don’t have the checks and

balances we want to prevent

process deviation.

We had 55% of our team

working for two months on

document generation alone.

I need an easy way to know

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

[Traceability](https://www.ketryx.com/capabilities/documentation#w-tabs-1-data-w-pane-0) [Preferred DevTools](https://www.ketryx.com/capabilities/documentation#w-tabs-1-data-w-pane-1) [SBOM](https://www.ketryx.com/capabilities/documentation#w-tabs-1-data-w-pane-2) [Documentation](https://www.ketryx.com/capabilities/documentation#w-tabs-1-data-w-pane-3)

Traceability

### Automatic Part 11-compliant audit trail

[Explore traceability](https://www.ketryx.com/capabilities/traceability)

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

[How we make Jira compliant](https://www.ketryx.com/use-case/jira-connector)

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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.

SBOM

### Software Bill of Materials (SBOM) Generation

[Explore SBOM](https://www.ketryx.com/capabilities/sbom-software-bill-of-materials)

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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

Documentation

### Configurable Audit-Ready and Submission-Ready DHF

[Download sample documentation](https://23261793.fs1.hubspotusercontent-na1.net/hubfs/23261793/Sample%20SRS.pdf)

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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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Continuous availability of technical documentation](https://www.ketryx.com/capabilities/documentation#)

Are You Building Medical Software?

## Get started building software in minutes, not months.

[Book a demo](https://www.ketryx.com/schedule-demo)

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