Medical Devices
Develop at the speed of software

From requirements management to change control, manage the entire medical device lifecycle across your IT systems in one place, and discover simplified compliance with a risk-based approach to safety-critical development.

Continuous compliance visibility throughout your


Controlled and connected.

Engineering teams face a rigorous process of maintaining knowledge across different IT systems, handling risk management, and ensuring all quality artifacts are ready and safe. Without the right tools and an organized onboarding process, teams face slow and expensive development with high turnover.

End-to-End Traceability

Design Documentation and other Artifacts

Collaborating Across Disparate IT Systems

Validation and Deployment


United IT systems. Simplified compliance.

Fortune 500 Medical Device teams use Ketryx to reduce complexity, accelerate development, and reduce the lifetime cost of regulated medical system.
You can too.

Continuous System Visibility

Passive and Active Product Surveillance

Compliant with IEC 62304, ISO 14971, CFR 21 Part 11

End-to-end GxP compliance visibility across your Software Development Life Cycle (SDLC). Automated workflows, remote audit, and extensive governance features.

Audit-ready Approach

Generate evidence with ease

Collect and store data at every stage for complete traceability

Prepare your device for FDA submission and future audits with a structured workflow for your team

Detailed Risk Assessments

Continuous evaluation of OSS dependencies for risks and other hazards

Automatic categorization of risks as they appear

Straightforward tables illustrate hazard levels and the recommend actions based on known information

Maintain Digital Knowledge Continuity

Understand and categorize each item in your system with simple, readable labels

Trace team actions, keep every team member up to date with the latest data, and follow actionable prompts

Use a self-contained system and lower the barrier for onboarding and teaching new team members

For the first time we have complete compliance visibility across our product lifecycle and IT systems.
20-year medical software veteran

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