The #1 validation platform for medical devices
Digitalize and manage validation end-to-end with the platform medical device leaders rely on across complex, multi-phase product lifecycles.
Handle equipment, process, sterilization, design, cleaning, CSV/CSA, and analytical instrument validation, all on one platform.
Meet FDA 21 CFR Part 11, EU Annex 11, and MDR expectations with complete traceability, secure audit trails, and real-time documentation.
Trusted By
One platform
Digital validation built for medical devices
Kneat is trusted by top medical device manufacturers worldwide. Digitalize and manage any validation process your way — in one flexible, compliant, end-to-end solution.
- Guided workflows aligned with FDA and EU MDR expectations
- Compliant electronic signatures and time-stamped audit trails
- Real-time in-document collaboration
- Automated traceability matrices
- Powerful document automation
- Continuous audit readiness
The solution
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Accreditations & Memberships
Printing the document, documenting everything by hand, capturing the screenshots, printing them out, labeling them, filing them...we saw a 46% reduction in time to execute, collect, and file digitized documentation using Kneat.
- Kathianne Ross, Manager of IT Compliance, Fujirebio Diagnostics Inc.
Book a DemoGet Started with Kneat
Support every phase of the medical device lifecycle with a digital validation system that streamlines processes, strengthens compliance, and improves team efficiency.
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