Ketryx

About Ketryx

Ketryx is a Connected Lifecycle Management platform for regulated medical applications, specializing in AI-driven compliance software. Trusted by 3 of the top 5 medical device manufacturers, Ketryx bridges the gap between development and regulatory compliance, reducing documentation burden by up to 90% through automated traceability and documentation. It enables teams to stay in their preferred tools while ensuring FDA, EU MDR, and ISO compliance, allowing innovation to move at the pace of technology without sacrificing safety or quality.

Products & Services

Ketryx Platform:A Connected Lifecycle Management platform for regulated medical applications, focusing on compliance with FDA, EU MDR, and ISO standards.

AI Agents:Automate tasks across toolchains with safety-critical AI agents that keep a human in the loop.

Traceability:Automatically creates a real-time requirements traceability matrix by connecting items, risks, code, and tests from all systems.

Documentation:Automatically compiles requirements, design inputs, outputs, and tests into a submission-ready design history file (DHF).

Enforcement:Enforces Quality Management System (QMS) procedures to ensure compliance with defined SOPs.

SBOM (Software Bill of Materials):Provides a consolidated view of the open-source supply chain directly from source code.

Requirements Management:Manages and traces requirements across connected systems like Jira.

Risk Management:Controls and documents risks in a 14971-compliant manner.

eQMS:An electronic Quality Management System interoperable with favorite tools for confident compliance navigation.

Specialties

AI-Driven Compliance Medical Device Software Development Regulatory Compliance (FDA, EU MDR, ISO) Lifecycle Management Traceability and Documentation Automation Quality Management Systems (QMS) AI/ML in Medical Devices Software as a Medical Device (SaMD)

Funding History

Debug: View Raw Funding Data

#	Type	Amount Fields	Date Fields	Investors
1	RT: Series B T: - FT: Series B	A: 39000000 MR: - FA: 39 million FAN: 39000000	D: 2025-09-04 FD: 2025-09-04	6 investors
2	RT: Series A T: - FT: Series A	A: 14000000 MR: - FA: $14 Million FAN: 14000000	D: 2023-12-05 FD: 2023-12-05	3 investors

Series B Latest

2025-09-04

$39.0M

6 investors (Pro only)

Series A 2023-12-05

$14.0M

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Growth Metrics

+45%

Employee Growth

YoY

3.2x

Funding Growth

Last Round

12

Markets

Operating

10K+

Customers

Active

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Team & Leadership

S

Sham Sokka

Chief Operating and Technology Officer for Digital Health

H

Helmut Hoffer von Ankershoffen

Senior VP Product and Engineering

M

Mihir Naik

Senior Director, Quality

C

Chen Weitz

Senior Engineering Director

A

Aaron Berlin

SVP Development and Engineering

E

Emre Gültürk

VP of Regulatory Affairs and Quality Systems

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Recent News

Ketryx Announces New Product Launch

2 days ago

Company unveils innovative solution to transform the industry, expanding market reach and capabilities...

Leadership Team Expands with Industry Veteran

1 week ago

New executive brings 20+ years of experience to accelerate growth and strategic initiatives...

Company Recognized as Industry Leader

2 weeks ago

Receives prestigious award for innovation and customer satisfaction in competitive market...

Key Competitors

C1

Competitor Alpha

Series B · $50M raised

C2

Competitor Beta

Series C · $120M raised

C3

Competitor Gamma

Series A · $25M raised

C4

Competitor Delta

Seed · $10M raised