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Enterprise Layer Intelligence
Categories/Healthcare & Life Sciences/Ketryx
Ketryx

Ketryx

Founded 2021

Automate FDA compliance documentation and requirement traceability for medical development

Pricing model

Free

You can use Ketryx to automate technical documentation and regulatory compliance tracking while building medical software and devices. It connects directly with systems like Jira and GitHub to trace requirements, risks, code changes, and test results as engineers write code. The system generates audit-ready documentation for standards like FDA, EU MDR, and ISO 13485. Instead of spending weeks compiling compliance paperwork manually, product teams can enforce quality controls in the background, validate machine learning models, and release regulated software updates much faster without risking regulatory penalties.

What Ketryx does

Generate compliant design history files automaticallyLink software requirements directly to test execution resultsTrack risk mitigations against specific code commitsProduce technical files for EU MDR conformity assessmentsValidate software changes against predetermined quality gatesReview traceability matrices across multi-component medical devicesAutomatically generates technical documentation as code is committedReal-time bidirectional traceability across requirements, risks, code, and testsIntegrates directly into Jira and GitHub developer workflowsAutomated enforcement of quality management system processesVerification and validation tracking for medical artificial intelligence modelsPre-configured regulatory frameworks for FDA, EU MDR, and ISO 13485Continuous audit readiness without manual document compilation

Pricing breakdown

Pricing model: Free

PlanList price
Free (paid yearly)Free

Frequently asked

JiraJiraGithubGithub

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Ketryx, medical device compliance, FDA compliance, ALM, IEC 62304, ISO 13485, EU MDR, automated traceability, risk management, QMS enforcement, Jira integration, GitHub integration, medical software development, audit readiness, regulatory compliance