Accelerate Product Innovation with the AI Partner to Fortune 500 Life Science Companies
Navigate compliance in the AI era with Ketryx
Build faster with regulated AI experts.
Our teams can help implement AI both within your organization and across your product lifecycle, strengthen cybersecurity, and optimize regulatory documentation. With deep expertise in medical device development and regulatory compliance, we help you release faster and scale with confidence.
Enterprise-Grade Expertise
Trusted by top medtech companies. .
Faster Time to Value
Reduce onboarding and migration overhead.
Built for Scale
Services tailored to the needs of your expanding product innovation.
AI and Your Product Maturity Model

Meet our
Innovators
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.
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.
AI QMS Development

AI Transformation
QA/RA Advisory
Agile Transformation

“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.”


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