Skip to main content
About Ketryx

Shaping the Future of Medical Device Software Compliance

What if regulated software teams could release high-quality software 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 software performs as intended without unforeseen or negative outcomes. At Ketryx, we endeavor to build tools that eliminate human error, self-correcting 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that Quality and Regulatory teams demanded highly documented, risk-based processes, yet developers were hindered by outdated tools and cumbersome manual approvals typical in compliance workflows.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.

Friction in the development of compliant medical device software delays life-saving technologies from reaching the market.
Developers have been slowed down by outdated tools and cumbersome processes  in compliance workflows.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 simplifies regulated software challenges through direct integration with tools like Jira and GitHub, automating documentation, and enforcing quality management systems.

Friction in the development of compliant medical device software delays life-saving technologies from reaching the 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 automatically generating FDA-compliant documentation from active workspaces, thus removing onerous documentation burdens. Additionally, Ketryx enforces QMS procedures and curtails process deviation using popular development tools like Jira and GitHub, streamlining compliance.

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

Erez Kaminski

Read bio
CTO & Founder

Jan Pöschko

Read bio
COO

John Koontz

Read bio
VP of Regulatory Strategy

Paul Jones

Read bio
VP of Marketing

Brian Katzman

Read bio
SVP of Sales

Zack Jha

Read bio
VP of Client Operations

Jake Stowe

Read bio