
Cleaning validation
Validate and document cleaning processes to ensure removal of residues, contaminants, and microorganisms to maintain product safety and quality.
Solutions for Medical Device
Assure QSR compliance and accelerate medical device validation with Kneat
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Ensuring a medical device meets user needs and intended uses through design validation is critical, as flaws impact patient safety. Kneat centralizes, automates validation, and streamlines technology transfer for efficient compliance and innovation.
Medical devices and manufacturing equipment often incorporate software components. Validating software to ensure it performs reliably under all intended conditions is a complex task requiring specialized expertise. Kneat ensures traceable, repeatable testing processes.
Adhering to regulations such as the FDA's QSR, which governs the design and manufacturing processes of medical devices, requires meticulous validation of all quality-related aspects. Kneat automatically tracks and documents compliance and enables seamless, controlled auditor access.
Ensuring suppliers’ components meet specifications is critical, as variability in materials or processes can impact device quality. Kneat streamlines supplier validation by centralizing supplier audit, material inspections, and verification testing, minimizing the risk of failure or recall.
It’s what I really wanted, the ability to still author and execute in the traditional manner, but not having the ‘on paper’ anymore.
Manager IT Compliance, Fujirebio Diagnostics, Inc
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