Nouveauté ! Développez votre produit SxMD avec un eQMS structuré comprenant des modèles SxMD prêts à être audités et conformes aux normes EU et US. En savoir plus !
Modernize your quality management culture.
Deliver high-quality SxMD solutions on time with a software platform that connects you to real-time, accurate, traceable data for your product and quality records.
Optimize digital quality processes
Fast track your quality processes using a digital software platform to create, trace, search, archive, and approve quality documentation throughout the product lifecycle.
Train & onboard with confidence
Easily manage, track progress, and assign role-based training to ensure teams stay up-to-date and qualified while centralizing training records to quickly demonstrate compliance in your next audit.
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User-friendly change management
Build efficient workflows to digitally document and control ongoing change processes like SOP, design specs, inventory and forms in a central platform with Part 11 compliant eSignature.
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Achieve SxMD CAPA excellence
Identify and resolve non-conformities with digital CAPA management that automates notifications and approval workflows to prevent bottlenecks.
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Simplify risk management
Unify risk-related activities by integrating your design, development and quality infrastructures to quickly identify and mitigate risk throughout the life cycle without adding to your workload.
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Hear from our customers
“Whether a device has 50 requirements or 500, we can generate accurate, complete documentation within seconds.”
Nick Alexander, System Engineer
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