Pure Global has introduced AI Builder, a groundbreaking platform designed to streamline the global regulatory submission process for medical devices. By automating documentation and regulatory analysis, this innovative tool can reduce submission preparation time from weeks to days, making it easier for MedTech companies to enter new markets.

The AI Builder platform works by extracting key data from manufacturers’ existing regulatory dossiers, performing gap analysis against target market requirements, and generating draft submission documents. This eliminates the need for redundant work, where companies often rebuild their entire regulatory file separately for each new country. As CTO Ran Chen notes,

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• https://justainews.com/industries/healthcare-and-medical/pure-global-rolls-out-ai-builder/

Sources

• pureglobal.com