Overview

Ketryx offers a SaaS Connected Lifecycle Management platform for regulated medical software. It guides the full lifecycle from planning through verification and maintenance, ensuring compliance with FDA, IEC 62304, GMP, ISO 13485, and CFR 21 Part 11. The platform integrates traceability, documentation, Jira, and SBOM management to streamline development, quality, and compliance. It targets MedTech teams from startups to large enterprises, aiming to reduce compliance risk and development costs while speeding time to market.

Simplify's Take

What believers are saying

• Raised $39M Series B in September 2024 led by Transformation Capital.
• Signed RadNet, HeartFlow, Nutrino in 2024, impacting 20M+ patients.
• Hired Zack Jha as VP Sales, Randall Markham as Chief of Staff in 2024.

What critics are saying

• PTC Codebeamer poaches Fortune 500 clients using Zack Jha's relationships.
• FDA 2026 AI/ML framework invalidates Ketryx AI Agents, demands rewrites.
• Open-source Polarion ALM diverts startups to free IEC 62304 alternatives.

What makes Ketryx unique

• Ketryx's validated AI Agents reduce compliance work by 90% in Jira and GitHub.
• Platform automates FDA-compliant SBOM and traceability for MedTech software.
• Trusted by 4 of top 5 medical device manufacturers for lifecycle management.

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Funding

Total Funding

$57M

Meets

Industry Average

Funded Over

4 Rounds

Notable Investors:

Lightspeed Venture Partners

Notable Investors:

Lightspeed Venture Partners

$39,000,000

Series B

Sep 2025

Series B funding is typically for startups that have proven their business model and need more funding to expand rapidly—often by entering new markets or adding more products. Investors are usually venture capital firms that specialize in later-stage investments.

Series B Funding Comparison

Above Average

Industry standards

Ind Avg. $35M

$4M

$30M

$39M

$45M

$65M

$100M

View all funding stages