Evolunic
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Agentic based SaaS for medtech compliance automation
Evolunic develops software that automates compliance tracking and change impact analysis for industrial teams managing complex projects. It integrates with CAD, ERP, and PDM tools to streamline workflows. Change impact intelligence flags affected requirements, tests, and risks instantly when design changes occur, eliminating manual triage. The system identifies recall scopes by analyzing device history records. The platform generates regulatory documentation aligned with ISO and EU standards, unifying inspection data, supplier certificates, and design records for traceability. It automates post-market event management by classifying complaints and assessing thresholds. Features include root cause analysis, V-model traceability linking hardware and software, and live audit support with AI-driven assessments.
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What is Evolunic?
Evolunic is a technology vendor specializing in digital transformation solutions. The company focuses on providing innovative software and consulting services that help organizations enhance their operational efficiency and adapt to changing market demands. With a commitment to leveraging advanced technologies, Evolunic aims to empower businesses through tailored solutions that drive growth and improve customer experiences. Their expertise spans various industries, enabling them to deliver customized strategies that align with clients' specific needs.