We validate AI-driven and regulated systems through rigorous testing, automation, and compliance-ready quality gates
We validate AI-driven and regulated systems through rigorous testing, automation, and compliance-ready quality gates.
We bring structure, transparency, and accountability to validation—especially for regulated environments.
Rigorous QA processes built into every stage to ensure reliable, high-standard delivery.
Clear test plans, traceability, and reporting - so stakeholders always know what’s validated and what’s next.
Deep knowledge of MDR/FDA-aligned validation, ISO 13485 practices, and quality gates used in regulated delivery.
From requirements and test strategy to evidence packages, risk alignment, and validation reports.
Proactive preparation for external audits and inspections through structured validation evidence and review cycles.
Define testing depth based on risk, criticality, and compliance constraints.
Plan coverage mapping, environments, test data, and acceptance criteria.
Manual, automated, and firmware testing—AI agents where they add speed and consistency.
Internal gates aligned with MDR/FDA expectations for traceability and completeness.
Structured documentation and validation packages ready for review and audit.
Clear validation signals and release readiness.
Early detection through structured QA and quality gates.
Repeatable testing via automation and UI-based AI agents.
Documentation and evidence aligned with regulated expectations.
Whether you need a full validation strategy or execution support, we help you ship compliant, testable, and reliable systems.
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