Ketryx logo — Develop fast. Stay compliant.

Ketryx

Develop fast. Stay compliant.

Founded 2021 United States Cambridge, United States 145 employees Series B Total: $57.05M Information Technology, Internet

General Information

Company Name Ketryx
Founded Year 2021
Location United States Cambridge, United States +1
Employees 145
Industries Information Technology, Internet
Funding Stage Series B
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AI Insight

Bounce Watch AI
2 months ago

Ketryx has achieved significant market validation through a strategic partnership and major customer win with Meta's Reality Labs, demonstrating its AI-native compliance platform's critical role in applying medical-grade rigor to advanced AI-enabled devices. This collaboration, alongside a reported 150% increase in release frequency for a Class II device, powerfully illustrates Ketryx's ability to accelerate regulated product development and close compliance gaps. Sponsoring the ISPE AI in Life Sciences Summit further solidifies its position as a key thought leader in AI/ML validation, signaling robust market traction and strategic expansion.

Signal Types
Customer Win Partnership Traction Event Participation Hiring
Strategic Labels
Market Validation AI Compliance Leadership Product-Market Fit
Next Move: Expansion
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Impact: 9/10
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Ideal For: Growth Equity Investors – Regulated SaaS/AI in Healthcare

About Ketryx

Ketryx, founded in 2021, is an American startup specializing in Information Technology and the Internet. The company is on a mission to revolutionize the product lifecycle management for regulated industries, particularly focusing on medical devices. Prominently known for their slogan, "Develop fast. Stay compliant," Ketryx is trusted by four of the world’s top five medical device manufacturers.

Through its AI-native compliance platform, Ketryx automates documentation processes, enhances traceability, and expedites release cycles without altering existing workflows. Their AI Agents significantly reduce manual effort by 90%, thus closing compliance gaps and enhancing both speed and quality in product deliveries.

Having raised a $39.00M Series B investment on 01 September 2025, Ketryx is backed by prominent investors such as E14 Fund, Lightspeed Venture Partners, Transformation Capital, Ubiquity Ventures, and Fifty Three Stations, underscoring their potential to make impactful strides in their sector.

Taxonomy: AI-native compliance platform, Medical device compliance, Product lifecycle management, Regulated software development, Automated documentation, Traceability, Risk management, Quality management system, IEC 62304, FDA compliance, ISO 13485, ISO 14971, 21 CFR Part 11, V-Model, eQMS

Services & Products

AI-native compliance for medical applications
Accelerating AI/ML software development
Compliance integration into existing development tools
Automated requirements and risk traceability
Automated documentation and report generation
AI-powered change impact assessment

Target Customers

Medical Device Manufacturers Life Sciences Teams AI/ML Product Teams Quality Assurance Teams Regulatory Affairs Teams R&D Teams

Funding Rounds & Investors (4)

View All
Funding Stage Amount Investors Lead Investors Date
Series B •••••• 5
Investor Investor Investor Investor
•••• ••••
01 Sep 2025
Series A •••••• 3
Investor Investor Investor
01 Dec 2023
Early VC •••••• - 01 Jun 2022
Seed •••••• - 01 Nov 2021

Ketryx Alternatives & Competitors

Ketryx vs

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FAQ About Ketryx

Develop fast. Stay compliant.
Ketryx was founded in 2021.
Ketryx is headquartered in Cambridge, United States.
Ketryx operates in the following industries: Information Technology, Internet.
Ketryx has approximately 145 employees.
Ketryx has completed 4 funding rounds, raising a total of $57.05M. The latest funding stage is Series B.
Ketryx offers: AI-native compliance for medical applications, Accelerating AI/ML software development, Compliance integration into existing development tools, Automated requirements and risk traceability, Automated documentation and report generation, AI-powered change impact assessment.
Top alternatives and competitors to Ketryx include MyBlueLabel Compliance Services, Cosmetri by Registrar Corp, MethodSense, Inc., InVita Implant & Explant Lifecycle Management Division, Matrix Requirements. These companies operate in related industries and serve comparable markets. You can compare them side by side on Bounce Watch.
Ketryx and MyBlueLabel Compliance Services are both companies in similar industries. Compare their funding, team size, growth signals, and market position on Bounce Watch to see which one fits your needs.

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