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Ketryx

Category: AI in Healthcare

An AI-driven compliance platform that automates and streamlines the entire software development lifecycle for medical device and life sciences companies. Ketryx was founded in 2021. The company is led by Erez Kaminski. Based in Cambridge, MA, USA. Team size: 11-50. Total funding raised: $18M+. Latest round: Series A. Key investors include Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures.

Founded
2021
Headquarters
Cambridge, MA, USA
Team size
11-50
Total funding
$18M+

Value proposition

Enables companies to build and release FDA-regulated software up to 3 times faster by automating compliance documentation and integrating quality management directly into the development workflow.

Products and solutions

Ketryx Connected Lifecycle Management Platform

Unique value

Ketryx's uniqueness lies in its developer-first, AI-powered approach. It connects and integrates the entire development and compliance lifecycle, embedding quality management into existing developer tools rather than forcing teams to use a separate, cumbersome system. This significantly reduces manual documentation and review.

Target customer

Regulated product teams in the medical device, MedTech, and life sciences industries that need to comply with FDA, EU MDR, and ISO standards.

Industries served

Medical Devices, Life Sciences, MedTech

Technology advantage

The primary advantage is a significant acceleration of the product development timeline in a highly regulated industry. By automating compliance and validation, Ketryx reduces the risk of regulatory rejection and allows for faster innovation and market entry. Their platform is also designed to validate the use of AI/ML in medical devices, a key emerging area.

How they differentiate

Ketryx differentiates itself by offering a developer-first, AI-powered platform specifically for medical device software compliance. Unlike traditional electronic Quality Management Systems (eQMS), Ketryx integrates directly into existing software development workflows (like Jira, GitHub), automating documentation and compliance tasks for standards such as IEC 62304 and ISO 13485. Its primary competitors are often internal, manual processes or general-purpose tools not built for regulated environments.

Main competitors

Greenlight Guru, Qualio, MasterControl

Key partnerships

Lightspeed Venture Partners (Investor), Ubiquity Ventures (Investor), Integration partnerships with development tools like GitHub, Jira, and Azure DevOps

Notable customers

Public information on specific notable customers is not available.

Major milestones

Raised $14M in a Series A funding round led by Lightspeed Venture Partners in December 2023., Announced that software developed on its platform has reached over 20 million patients., Launched Ketryx Intelligence, an AI-powered feature to automate the generation of requirements, tests, and documentation.

Growth metrics

Publicly available growth metrics are limited. The company has stated its platform has been used to develop software that has impacted over 20 million patients.

Market positioning

Ketryx is positioned as an innovator in the niche market of Application Lifecycle Management (ALM) for regulated medical software. It targets software development teams within MedTech companies, aiming to significantly reduce the time and cost of achieving and maintaining FDA and EU MDR compliance.

Geographic focus

Ketryx primarily focuses on the North American and European markets, as evidenced by its emphasis on compliance with regulations from the FDA (United States) and EU MDR (European Union).

Patents and IP

Information on specific patents is not publicly available.

About Erez Kaminski

Previously, Erez Kaminski was the Head of AI/ML for Medical Devices at Amgen, a global biotechnology company. He also has experience as a computational mathematics researcher at Wolfram Research, the creators of Mathematica and Wolfram|Alpha.

Official website: