Interoperable medical device eQMS software

Traditional eQMS tools can be overwhelming, complex, and costly, creating bottlenecks in quality processes. Teams struggle with fragmented training management, cumbersome document approvals, and manual CAPA workflows, increasing the risk of non-compliance during audits.

Ketryx streamlines and accelerates quality management processes, with AI agents that augment the most time-consuming QMS tasks and a compliance assistant that answers the hard questions in seconds. Supporting compliance with 21 CFR Part 11, ISO 13485, ISO 14971, EU MDR, IVDR, and 21 CFR Part 820.

The best part of Ketryx is that no one needs to jump from one platform to another. Our developers don’t even need to engage with Ketryx if they’re doing their work in Jira, since Ketryx enforces our QMS there, and Quality can see everything in Ketryx.
Emre Gültürk, VP of Regulatory Affairs and Quality Systems at HeartFlow

Build audit-ready medical device software

Ketryx simplifies document control, training management, non-conformance reporting, and complaint handling, seamlessly integrating with your team’s existing tools like Jira, GitHub, and AWS. AI agents run continuously in the background, surfacing gaps, drafting corrective actions, and flagging issues before they become audit findings. By unifying all actions in a single system, Ketryx ensures traceability, accountability, and audit readiness—helping you pass internal and external audits. Minimal complexity. Maximum compliance.

Simplify document control

Ketryx simplifies document control with automated version control and role-based approvals. Your team can work on the latest version of any document while maintaining a full audit trail of changes.

• Centralized document repository (EDMS): Quickly access all your documents in one place, and easily search for the document you need.
• Automated workflows: Create, manage, and approve documents with automated notifications keeping everyone informed of revisions.
• Google Drive integration: Sync changes directly from Google Drive into Ketryx, eliminating manual transfers while preserving audit trails.

Automate training management

Ketryx tracks required training, monitors who needs it, and verifies completion status through role-based assignments.

• Comprehensive Training Overview: View all required training and completion status for each individual.
• Automated Assignments: Assign training based on roles and responsibilities.
• QMS Enforcement: Prevent actions from individuals who are not trained for the task.

Automate CAPA and non-conformance management

Handle non-conformances and associated Corrective and Preventive Actions (CAPAs) with automated workflows and root cause analysis integration in Ketryx. Track CAPA progress from initiation to closure, ensuring that issues are addressed and resolved efficiently, with full traceability throughout the process.

• AI-drafted CAPAs: Draft corrective and preventive action plans from non-conformance data, gated by human review and approval.
• Traceability: Link non-conformance events to CAPAs, ensuring corrective and preventive actions are properly executed and tracked.
• Risk Management: Built-in risk assessment tools allow for continuous monitoring.

Comprehensive complaint management for post-market surveillance

Ketryx integrates complaint handling with CAPA management and post-market surveillance. Track complaints, investigate root causes, and take corrective action with full traceability.

• AI-driven analysis and detection: Identify complaint patterns and surface emerging risk signals before they escalate.
• Dashboarding and Reporting: Easily search and generate reports on complaint status.
• End-to-End Traceability: See full traceability and tracking of complaints throughout the product lifecycle.
• Integrations: Trace complaints from systems of work to CAPAs in Jira, Ketryx, or another eQMS.

Keep your e-signatures Part 11-compliant

Ketryx is designed with 21 CFR Part 11 compliance at its core. With biometric authentication built right into the browser of your choice, you can rest assured that your approvals and signatures meet regulatory standards without extra steps or software.

• Configurability: Use different approval rules for different documents, assign specific approvers as necessary, and decide which item types require an electronic signature.
• QMS Enforcement: Block approvals and signatures from people without the required training.

Ensure compliance with design and development controls

Medical device quality management requires linking product requirements with validation results to ensure the final product meets all regulatory standards. Ketryx supports design control processes, providing complete traceability from design inputs to validation, making it easy to demonstrate compliance during audits.

• AI-assisted gap detection: Ask Ketryx Assistant which requirements lack test coverage or design outputs. Get concrete answers in seconds, grounded in end-to-end traceability.

• Validation: Ensure that product requirements are fulfilled by the final product.

• Traceability: Trace complaints to the design controls they affect, and ensure full traceability from design history to final product.

• Compliance: Stay compliant with 21 CFR 820 (QMSR), EU MDR, and ISO 13485.

Implement controlled changes

Implement controlled changes with ease. Ketryx ensures that every process, document, or product change is tracked, evaluated, and approved by the right people. Change impact assessments help you know how changes affect compliance and product quality.

• Change Management: Control change workflows with electronic approvals.
• Change Impact: AI-powered change impact assessment identifies affected items across your Design and Development File in minutes, reducing cycle time by up to 70%.
• QMS Enforcement: Configure Ketryx to transition items out of a controlled state if it observes any changes to the controlled record for that item.

End-to-end traceability across the product lifecycle

End-to-end traceability from design to post-market activities ensures you can link product requirements, files, and test results. Ketryx makes it easy to maintain and retrieve these records, providing a clear picture of your product's lifecycle.

• Interoperability: Link requirements, designs, and tests for complete traceability, whether these items are stored in Jira, TestRail, GitHub, or elsewhere.

• RTM Configuration: Configure the columns, checks, and error levels of your traceability matrix (i.e. "All major nonconforming product events shall be corrected by a CAPA").

• Documentation: Maintain and retrieve Design and Development Files and Medical Device Files (MDF).

• Compliance: Stay compliant with 21 CFR 820 and ISO 13485 standards.

Integrate risk management

Ketryx offers integrated and configurable risk management, including risk matrices and documentation of Failure Modes and Effects Analysis (FMEA), ensuring that you can assess, prioritize, and mitigate risks at every stage of your product lifecycle.

• AI-drafted risk items: Generate failure modes, hazards, and risk controls from prompts, reviewed and approved before implementation.
• Risk Matrix: Visualize risks with integrated risk matrices.
• Traceability: Track risk mitigation strategies from initial assessment through to resolution.
• QMS Enforcement: Define your risk management process in Ketryx and ensure it is followed automatically, enforcing your risk matrices, standard lists of hazards/harms, and more.

Maintain audit readiness with extensive GxP validation evidence

Ketryx is validated for GxP purposes, ensuring your system is audit-ready at all times. With detailed GxP evidence and audit trails, you can confidently show auditors how Ketryx supports your Quality Management System—from CAPA management to training records.

• Ketryx Assistant for audits: Ask any question about your QMS during an audit and get cited answers from your source documentation instantly.
• Validation Documentation: Ensure your team is compliant from day one, so you can pass internal and external audits with ease.
• Control Records: Ketryx ensures that all records are accessible, searchable, and compliant, allowing you to demonstrate full audit readiness at any time.

AI quality oversight across your entire TPLC

Ketryx AI Agents work continuously in the background, analyzing non-conformances, reviewing CAPA status, monitoring complaint trends, and flagging traceability gaps. Each morning, your quality team gets a summary of findings with actionable recommendations, ready for human review. No black box. No hallucinations going undetected. Every AI action is reviewed, approved, and Part 11-compliant.

• Quality Review Agent: Nightly analysis of items against QMS standards, findings emailed with suggested redlines.
• CAPA Agent: Drafts corrective action plans from non-conformance data.
• Complaint Monitoring Agent: Surfaces complaint trends and high-severity signals before they escalate.