This is some text inside of a div block. # About Ketryx ## We’re building the future of regulated AI Ketryx helps high-performing teams move at the speed of AI, without compromising on compliance. Built by and for engineers in medtech, our platform brings safety and velocity together in one seamless system. Trusted By: .png) .png) ## Built for scale. Proven in the field. "With Ketryx, we automated and streamlined far more than expected. Work that would have taken us a year was completed in just 90 days because of their expertise, partnership, and platform. Had we chosen another provider, our confidence and our timeline would have looked very different." **Tsimafei Savitski,** Chief Legal and Compliance Officer, Flo Health 0 of 5 Top medtech firms 0M+ Patient lives improved 0x Faster development 0% Reduction in documentation time ## Strategic capital from across the industry From Fortune 500 to high-growth innovators, companies building life-saving software rely on Ketryx to scale fast, and prove compliance at every step. Investor Spotlight Guru Chahal Partner Bill Hawkins Chairman and Former CEO Vinay Shah Partner & Founding Member "Ketryx is uniquely positioned to help companies around the world develop software faster while remaining safe and compliant." Guru Chahal Partner Lightspeed Lorem ipsum Michal Preminger Former Head of Innovation Massbio “I love what Erez and team have built. I wish it was available when I was running Medtronic." Bill Hawkins Chairman and Former CEO Medtronic "Fortune 500 giants and fast-growing innovators consistently praise Ketryx for proving that compliance can accelerate progress." Vinay Shah Partner & Founding Member Transformation Capital ## Our Mission Make regulated systems safe and reliable through technology. ## Our Vision A world where products perform without unintended harm. ## Who we serve Teams building the most critical software in the world, who can’t afford to get it wrong. ## Founded by builders who lived it ### From research project to industry platform **2021** ### Founding Ketryx While leading AI and ML initiatives at Amgen, **Erez Kaminski** hit a persistent blocker: Quality and Regulatory teams required high assurance and documentation, but existing tools couldn't keep up. In 2021, Erez co-founded Ketryx with **Jan Pöschko** from Wolfram Research. Their vision: use AI and deterministic systems to make regulated software development as seamless as modern unregulated workflows, because software teams shouldn't have to choose between velocity and validation. That year, they brought on FDA regulatory veteran Paul Jones and began building the first integrations for Jira and GitHub. **2022** ### First Customers, First Proof Points With seed funding from MIT's E14 Fund and Ubiquity Ventures, the team got to work building the core platform: a central orchestration layer that could connect tools like Jira and GitHub into a single, traceable software development lifecycle. That year, Ketryx signed its first customers, proving that regulated teams no longer had to choose between modern dev workflows and compliance. **2023** ### Series A and Scaling Ketryx closed a $14M Series A led by Lightspeed Venture Partners, with continued backing from E14 Fund and Ubiquity Ventures. The funding fueled a push to scale the product and commercial engine as demand from regulated software teams (especially those building AI-powered medical devices) began to outpace the founding team's capacity. By year's end, the company had raised over $18M. **2024** ### Product-Market Fit, Enterprise Growth Ketryx signed leading MedTech manufacturers and began working with three of the world's top five medical device companies. Products built on Ketryx accounted for 2-3% of all FDA AI/ML software approvals, and the platform's reach grew to impact over 20 million patients. The team shipped its best in-class AI-powered technology including requirement creation, suggested traceability links, and auto-generated release notes, along with FDA-ready SBOM generation and new integrations. Key hires rounded out a leadership bench built for scale. Ketryx also renewed its UL Certifications and heightened compliance standards. **2025** ### Series B and the Future of Safe AI Ketryx launched the industry's first validated AI Agents for regulated industries, reducing manual compliance work by 90% while keeping humans in the loop for safety-critical decisions. In September, Ketryx raised a $39M Series B led by Transformation Capital. Former Medtronic CEO Bill Hawkins joined as an investor, alongside continued support from Lightspeed, E14 Fund, Ubiquity Ventures, and 53 Stations. Total funding crossed $55M, and the company accelerated global expansion, growing teams in Boston and Vienna. **2026** ### Regulated AI at Scale Ketryx entered 2026 with its strongest momentum to date. Four of the top five Fortune 500 MedTech companies now run on the platform, and Ketryx-powered products reach more than 100 million patients worldwide. As demand for validated AI surges across life sciences, Ketryx is proving that safety-critical product development no longer has to be slow, and that AI-assisted compliance infrastructure for regulated products is a competitive necessity. ## 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. **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. **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. **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. **Tim Brodeur** VP, Success & Delivery Tim is a life sciences software leader who built success teams at Veeva, Benchling, and Causaly. **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. **Randall Markham** VP, Operations & Finance Randall is an operations leader with experience driving performance across industrial, defense, and technology organizations. ## A culture that reaches to build it right the first time We take our mission seriously, but not ourselves. Our culture blends transparency, discipline, and momentum, because you can’t build safety at scale without all three. Sound like your kind of team? #### Move On What Matters Take the first step. We move fast on what matters most—prioritizing action, momentum, and meaningful outcomes over unnecessary tinkering. We don’t chase perfect; we always deliver, iterate, and learn. #### Give Autonomy. Own It. Leaders create goals, clarity, and context. From that, we push decisions, ownership and accountability to the people closest to the problem. They own them and follow-through without prompting. #### Scale Quality to Consequence We take a risk-based approach; apply the highest standards where they matter most. In patient-impacting systems, we pursue excellence. For internal work, speed and iteration are often the right trade-off. #### Continuously Learn We believe in continuous improvement. We get better every day—individually and as a company. This is about constant feedback loops, candid and caring conversations, iteration, self-reflection, and experimentation. #### Chase Problems Together We take on meaningful, ambitious challenges—side by side. We move as a team, lift each other up, and celebrate shared wins before scaling the next peak. #### Do What Compounds We invest in the things that grow in value over time—skills, systems, people, relationships, and habits. We prioritize our enduring advantage, and we build with tomorrow in mind. ## The industry is paying attention Our approach to AI, safety, and compliance has been featured in Boston Business Journal, R&D World, and more. **Erez Kaminski, Co-Founder & CEO at Ketryx on serving 100M+ customers and scaling regulated products** MGMT Boston - The Lantern • April 7, 2026 **Watch how Ketryx applies AI to automate compliance in regulated software** CIO • February 11, 2026 **The VentureFizz Podcast with Erez Kaminski** VentureFizz • September 15, 2025 **AI firm Ketryx raises $39M, adds former Medtronic CEO as investor** MedTech Dive • September 4, 2025 **Ketryx Raises $39M Series B from Transformation & Lightspeed to Scale AI in MedTech** Sourcery • September 4, 2025 **Why Validated DevOps is the Path Forward for Regulated Software** devops.com • January 30, 2025 ## Built for the bold # Let’s make compliance move at the speed of innovation AI is changing everything. But in regulated spaces, speed without safety isn’t an option. Ketryx helps the world’s most ambitious teams move fast, with zero lag on compliance, safety, or trust.