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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.

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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

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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

Former Chairman and 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

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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

Former Chairman and 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 Investors:

Also Invested In:

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

2022

2023

2024

2025

2026

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.

2021

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.

2022

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.

2023

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.

2024

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.

2025

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.

2026

An Extension of Your Team

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.\Previously:\n](/content/about/company#/index.html)

*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.\Previously:\n](/content/about/company#/index.html)

*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.\Previously:\n](/content/about/company#/index.html)

*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.\Previously:\n](/content/about/company#/index.html)

*Tim Brodeur* \ VP, Success & Delivery\Tim is a life sciences software leader who built success teams at Veeva, Benchling, and Causaly.\Previously:\n](/content/about/company#/index.html)

*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.\Previously:\n](/content/about/company#/index.html)

*Randall Markham* \ VP, Operations & Finance\Randall is an operations leader with experience driving performance across industrial, defense, and technology organizations.\Previously:\n](/content/about/company#/index.html)

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?

How we show up every day

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

In the News

Our approach to AI, safety, and compliance has been featured in Boston Business Journal, R&D World, and more.

Former Medtronic CEO Joins Ketryx Board

Medical Product Outsourcing, • June 25, 2026

Ex-Medtronic CEO Bill Hawkins joins Ketryx board

Medical Design & Outsourcing, • June 25, 2026

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

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.