This is some text inside of a div block.

# End-to-End AI Transformation for Product Innovation

## Accelerate the way you build innovative products in the AI era.

With Ketryx, Fortune 500 Life Science Companies can now have an AI Partner embedded in your organization during AI implementation.

# Pathways to Accelerated Product Innovation

## AI and Your Product Maturity Model

Through Ketryx, organizations can strategically leverage AI to advance their product and software maturity model, guided by our team of experts. We help you define and implement a robust AI strategy, deploy intelligent AI agents to automate critical tasks, and integrate automation across your development lifecycle. This comprehensive approach ensures continuous improvement, allowing you to build and release innovative products more efficiently and compliantly.

### Enterprise-Grade Expertise

Trusted by top medtech companies.

### Faster Time to Value

Reduce onboarding and migration overhead.

### Built for Scale

Services can expand with product innovation.

# A Quality System Designed for AI-Enabled Devices

- Deploy an AI-ready QMS with pre-defined procedures for data management and model training.
- Integrate AI-specific provisions into ISO 13485, ISO 14971, and IEC 62304 frameworks.
- Map toolchains, identify compliance gaps, and build tailored action roadmaps.
- Deliver a validated QMS that supports safe, compliant AI innovation.

# Responsible, Validated AI Development

- Build and validate AI/ML systems aligned with FDA PCCP and EU AI Act.
- Proactively manage risks like data poisoning, bias, and model drift.
- Establish traceability across datasets, training runs, and deployed models.
- Enable faster, safer releases of AI-enabled medical devices.

# Strategic Quality & Regulatory Guidance

- Advisory support for submissions (510(k), De Novo, CE Marking).
- Gap assessments for QMS and inspection readiness.
- Expertise on CAPA, nonconformances, complaints, and postmarket surveillance.
- Access to senior Ketryx Quality Leads for V&V, process optimization, and audit preparation.

# Adopt Modern Ways of Working Without Losing Compliance

- Shift from document-heavy to item-centric compliance processes.
- Align Agile processes with regulatory expectations.
- Accelerate release cycles while preserving audit readiness.
- Coach development and QA/RA teams on Agile + compliance integration.

# Strengthen Cybersecurity & Compliance

- Generate and maintain a comprehensive Software Bill of Materials (SBOM) for regulatory compliance.
- Automate vulnerability management to identify and mitigate risks.
- Establish a repeatable process for managing third-party software components.

# Seamless Onboarding & Configuration

- White-glove Ketryx deployment and configuration tailored to your processes.
- Integration with Jira, GitHub, ALM & SDLC tools for automated traceability.
- Product training & enablement to accelerate adoption.

# Automate & Streamline Regulatory Documentation

- Templatize & standardize thousands of pages of technical and regulatory documents.
- Ensure consistent formatting and compliance with FDA, ISO, and IEC standards.
- Reduce documentation burden with automated evidence collection.

# On-Demand Compliance & Process Optimization

- FDA Part 11 validation & audit readiness.
- Cybersecurity compliance remediation to meet evolving regulations.
- Lifecycle development strategies, coaching, and training (including AI).

# What our MedTech clients are saying

## "Ketryx's expertise and dedication to customer success have made them an indispensable partner, and we look forward to continuing our collaboration to achieve even greater operational excellence."

Christy Hardin

Director of Quality Assurance,

DeepHealth - Radnet

[View case study](/content/case-studies/deephealth-case-study/index.html)

## The experts medtech teams trust

Contact us to see how Ketryx can accelerate your team’s AI maturity.

[Talk to an expert](/content/schedule-demo/index.html)