Unify medical device validation from hardware to SaMD to AI
Engineering-grade evidence for every layer of the device, ready when regulators are.
Outcomes
Validate non-deterministic AI/ML with controls for data integrity, model performance, and drift detection.
Maintain validated state across every release and model update with automated change detection, aligned to FDA CSA guidance.
Generate evidence packages, DHF components, and submission artifacts automatically. Every decision explainable, every output traceable.
Centralize validation across computerized systems, equipment qualification, process validation, and embedded software in one system of record.
Maintain complete design history with end-to-end traceability from user needs through design inputs, outputs, verification, and validation.
Run validation alongside your code through Jira, GitHub, and your testing stack. Aligned to IEC 62304 and FDA SaMD classifications.
For device organizations
Res_Q centralizes device, software, and equipment validation in one system of record. Built for Engineering, Quality, and IT teams shipping CDRH-regulated products.
For SaMD builders
GxPNext runs validation alongside how your team builds software, with continuous compliance for regulated apps and AI/ML.
"Sware is an extremely responsive organization, managing our entire relationship from initial discussions through final validation deliverables, which they provided quickly and professionally."
Steven Bishop | Chief Data Officer
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