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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.
About Ketryx
Industries
Data & Analytics
Enterprise Software
Healthcare
Company Size
51-200
Company Stage
Series B
Total Funding
$57.1M
Headquarters
Cambridge, Massachusetts
Founded
2021
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Simplify's Take
What believers are saying
- September 4, 2025 Series B raised $39 million; total funding exceeded $55 million.
- February 26, 2026 momentum release named Meta Reality Labs and Flo Health customers.
- March 31, 2026 MCP beta embeds compliance intelligence directly into AI workflows.
What critics are saying
- FDA QMSR effective February 2026 raises compliance expectations and implementation scrutiny.
- Veeva and Benchling can bundle adjacent workflow tools, compressing Ketryx pricing power.
- If validated AI fails an audit, Ketryx’s whole regulated-AI thesis breaks.
What makes Ketryx unique
- Ketryx connects Jira, GitHub, and QMS into traceable regulated-development workflows.
- May 1, 2025 validated AI agents automate documentation with human-in-the-loop controls.
- Four top-five Fortune 500 MedTech companies run Ketryx across regulated product teams.
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Funding
Total Funding
$57M
Meets
Industry Average
Funded Over
4 Rounds
Lightspeed Venture PartnersIndustry standards
Benefits
Hybrid Work Options
Unlimited Paid Time Off
Stock Options
Growth & Insights and Company News
6 month growth
↑ 2%1 year growth
↑ 9%2 year growth
↑ 7%Recently, Ketryx announced a $39M Series B round of funding led by Transformation Capital, with participation from existing investors including Lightspeed Venture Partners, MIT's E14 Fund, Ubiquity Ventures, and 53 Stations.
Ketryx, a Cambridge, MA-based AI-powered compliance platform helping life sciences companies ship safer products faster, raised $39M in Series B funding
Ketryx raises $39M Series B round to power the future of regulated artificial intelligence for life sciences.
Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B funding round led by Transformation Capital.
Ketryx launches first validated AI Agents to accelerate safety-critical product development.
Ketryx is Hiring for 9 Jobs on Simplify!
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About Ketryx
Industries
Data & Analytics
Enterprise Software
Healthcare
Company Size
51-200
Company Stage
Series B
Total Funding
$57.1M
Headquarters
Cambridge, Massachusetts
Founded
2021
Ketryx is Hiring for 9 Jobs on Simplify!
Find jobs on Simplify and start your career today