Shaping the Future of Medical Device Software Compliance
Our mission
Our vision
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.
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that Quality and Regulatory teams demanded highly documented, risk-based processes, yet developers were hindered by outdated tools and cumbersome manual approvals typical in compliance workflows.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.
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.
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.
Meet our
Innovators
Erez Kaminski
Erez is passionate about improving patient care and health outcomes with software solutions. Over the last decade, Erez worked in industries including computational mathematics, biotech, and energy, helping build monitoring systems for pharmaceutical equipment and AI for medication management. Before Ketryx, Erez worked with Amgen, the world’s largest biotechnology company, as the head of AI/ML for their medical device division and with Wolfram Research, the builders of Mathematica and Wolfram|Alpha. Erez holds a Master of Science in Electrical Engineering and Computer Science and a Master of Business Administration from the Massachusetts Institute of Technology.
Jan Pöschko
Jan led cloud development for Wolfram Research, where he and Erez worked together to launch developer tools used by millions of users each day (Wolfram|Alpha, Mathematica). He has over 15 years of experience as a software developer and infrastructure architect and for the last decade has been leading the development of the Wolfram Cloud, a developer-first infrastructure cloud technology stack. Prior to Wolfram, Jan was a visiting researcher at the Stanford Biomedical Informatics lab. He holds a Master of Science degree in Mathematical Computer Science from Graz University of Technology.
John Koontz
John has held roles in research, engineering, IT, and operations in the software industry for over 25 years. Most recently, he was both the VP of Engineering and Chief Information Officer for operations and compliance at Wolfram Research, primarily focused on Wolfram Alpha, the world's first and most trusted knowledge engine. He directed global platform operations and R&D efforts, as well as third party integration with customers like Apple, Amazon, and CVS-Health. His computer science and engineering experiences include large scale parallelized simulation models, design of high performance computing systems, directing IT architecture at a state university, and working for quality-focused research organizations such as Argonne National Lab and NASA. He holds a Master of Science degree in Computer Technology from Eastern Illinois University.
Paul Jones
Paul is a world-renowned software safety expert who joined Ketryx following 25 years at the Food and Drug Administration (FDA). He helped create the FDA’s approach to safety-critical software and medical devices and founded the FDA’s software engineering lab. While holding committee positions with groups that handled medical software safety standards like ISO 13485, ISO/IEC 62304, and ISO 14971, he reviewed over 300 devices, carried out numerous inspections, and provided training to FDA staff on software quality, risk management, and software engineering. Prior to the FDA, he worked 20 years as a systems/software engineer for companies like Ford Motor, Electronic Data Systems, Honeywell, and SAIC. He holds a Master of Science degree in Computer Engineering from Loyola University, Maryland.
Brian Katzman
Brian has been at the forefront of digital marketing for the past 20 years, starting with Google in 2003. He was the original marketing leader at Tile, responsible for the Bluetooth tracker’s meteoric rise and category dominance. Since that time, he has led marketing teams across several B2B and B2C companies. Most recently, he built a boutique consulting practice specializing in medical device manufacturers like iRhythm and Heartflow where he eventually met Erez and the Ketryx team. Brian holds an MBA and MS from the University of Michigan and a BA/BS from Northwestern University.
Zack Jha
Zack brings over 20 years of global sales and business development experience to Ketryx, with a proven track record in both start-ups and established, market-leading SaaS companies. Prior to joining Ketryx, Zack served as the Head of Business Development for the US-East Sales team at AWS, where he led the Industry Cloud Migration & Modernization initiatives. Before his tenure at AWS, Zack was the Vice President of Worldwide Sales & Strategy at PTC, where he spearheaded the creation and launch of industry-based go-to-market (GTM) sales strategies, achieving double-digit year-over-year (YoY) annual recurring revenue (ARR) growth. He is also the holder of U.S. Patent 10591898 for innovations in CAD-based design control systems. Earlier in his career, Zack led sales and business development for Oracle and two successful venture-backed companies in Silicon Valley. He holds an MBA from the Booth School of Business and a Bachelor of Engineering from BIT Mesra.
Jake Stowe
Jake brings experience that fuses technology and quality systems. His professional journey began in operations, fostering a deep understanding of complex, safety-critical systems; prior to Ketryx, he was a manager in a GMP pharmaceutical plant at Amgen. This foundation has profoundly shaped his approach to tech, where he currently serves as the Vice President of Client Operations at Ketryx. Jake holds an MBA in Operations and Logistics and a Master's degree in Systems Engineering from MIT, where he was a Leaders for Global Operations (LGO) Fellow.