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About Ketryx

Shaping the Future of
AI-Powered Compliance

What if regulated  teams could release high-quality products at the same speed as unregulated industries?
Ketryx CEO and Founder Erez Kaminski

Our mission

To make systems safe and reliable.

Our vision

A world where products perform as intended without unforeseen or negative outcomes. At Ketryx, we endeavor to build AI-based tools that eliminate human error and self-correct along the development journey to push the limits of innovation safely.
Ketryx Journey

Pioneering Change in MedTech

The Beginning

Driven by a lifelong passion for quality in medical care, Ketryx CEO and Founder Erez Kaminski identified a major source of friction in the regulated software development process while leading AI and ML at a major biotech company. This bottleneck slowed innovation and delayed life-saving technologies from reaching the market.

Friction in the development of compliant medical device software delays life-saving technologies from reaching the market.
Friction in the development of compliant medical device software delays life-saving technologies from reaching the market.

The Problem

Erez observed that Quality and Regulatory teams demanded highly documented, risk-based processes, yet developers were hindered by outdated tools and cumbersome manual approvals typical in compliance workflows. This dynamic persists industry-wide, with QA/RA frustrated by unmet SOPs and developers burdened by tedious documentation and antiquated processes suited to hardware-centric medical devices.

Developers have been slowed down by outdated tools and cumbersome processes  in compliance workflows.
Developers have been slowed down by outdated tools and cumbersome processes  in compliance workflows.

The Vision

Together with software veterens Jan Pöschko and John Koontz from Wolfram Research and FDA regulatory expert Paul Jones, Erez launched Ketryx. This venture redefines development, testing, and market introduction of medical device software. By leveraging collective expertise in compliance, software development, and AI/ML, Ketryx AI simplifies regulated software challenges through direct integration with tools like Jira and GitHub, automates documentation, and enforces quality management systems.

It’s time to revolutionize how medical device software is developed, tested and brought to market.
It’s time to revolutionize how medical device software is developed, tested and brought to market.

The Solution

Ketryx explores how regulated software teams might match the pace of unregulated sectors. It does so primarily by utilizing agentic AI to automatically generate FDA-compliant documentation from active workspaces, thus removing onerous documentation burdens. Additionally, Ketryx deterministic AI enforces QMS procedures and curtails process deviation using popular development tools like Jira and GitHub, streamlining compliance.

With Ketryx, regulated software teams can release high-quality software at the same speed as unregulated industries.
With Ketryx, regulated software teams can release high-quality software at the same speed as unregulated industries.
Ketryx Leadership

Meet our
Innovators

Ketryx is driven by a team of world-class developers, quality, and regulatory professionals, including key contributors to the IEC 62304 medical device standard. Our diverse team, located in Boston and across Europe, is committed to reducing the complexity of compliance to enable faster and safer software development.
Join the team
Erez Kaminski

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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Erez Kaminski

CEO & Founder
Jan Pöschko

Jan Pöschko

CTO & Founder
Jan is a veteran software and infrastructure leader who co-built Wolfram|Alpha and led Wolfram Cloud development for over a decade.
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Jan Pöschko

CTO & Founder
Mary Brook Delano

Mary Brook Delano

Chief Business Officer
Mary Brook is a commercial leader with a track record of scaling teams and driving $100M+ growth in life sciences.
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Mary Brook Delano

Chief Business Officer
Brian Katzman

Brian Katzman

Chief Marketing Officer
Brian is a veteran marketing leader who helped launch Tile and has spent two decades driving growth across leading tech and MedTech companies.
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Brian Katzman

Chief Marketing Officer
Tim Brodeur

Tim Brodeur

VP, Success & Delivery
Tim is a life sciences software leader who built success teams at Veeva, Benchling, and Causaly.
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Tim Brodeur

VP, Success & Delivery
Paul Jones

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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Paul Jones

VP, Regulatory Strategy
Randall Markham

Randall Markham

VP, Operations & Finance
Randall is an operations leader with experience driving performance across industrial, defense, and technology organizations.
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Randall Markham

VP, Operations & Finance