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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.

You’ll be working with experts from:

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).

An Extension of Your Team

Our People Make the Difference

Every engagement is backed by our team of Quality leaders and life science experts. From initial discovery to full-scale deployment, we’re an extension of your team.

Erez Kaminski
CEO & Founder
Passionate about advancing patient care through AI and software, with experience spanning Amgen, Wolfram Research, and MIT.
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Paul Jones
VP, Regulatory Strategy
A globally recognized software safety expert, Paul shaped the FDA’s medical software standards and advances safe, compliant development across life sciences.
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Lee Chickering
Director of Quality
An expert in quality assurance and regulatory compliance, Lee bridges quality management and customer success to advance efficiency, compliance, and innovation in life sciences.
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Matt Dumouchel
Director of Client Operations
Matt helps life sciences teams optimize digital operations and compliance through deep expertise in data systems, manufacturing, and process excellence.
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Bailey Canter
Director of Solutions
Bailey empowers life sciences teams to accelerate compliant software delivery through deep expertise in systems engineering, agile delivery, and DevOps.
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Gabriel Pascualy
Head of Product
An expert in device security and cyber-physical systems, Gabriel advances AI-driven MedTech innovation, cybersecurity, and compliance automation across leading life sciences organizations.
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Carlton O'Neal
Product Manager
Carlton bridges product management and operations to help life sciences teams streamline compliance, improve quality, and accelerate innovation.
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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

The experts medtech teams trust

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

Talk to an expert