Last Updated: 23 November 2025
Pure Global launched AI Builder, a new generative AI platform designed to accelerate the global regulatory submission process for medical devices. The tool, which automates documentation and regulatory analysis, can reduce submission preparation time from weeks to days, dramatically improving the speed, cost, and efficiency with which MedTech companies enter new markets.
AI Builder works by extracting key data from manufacturers’ existing regulatory dossiers (such as FDA 510(k) or CE-marking packages), then performing gap analysis against the requirements of target markets (for example, ANVISA in Brazil or COFEPRIS in Mexico).
From there, it generates draft submission documents, highlights missing information, and allows simultaneous preparation for multiple countries — all customized to each device and region.
This innovation comes in response to a common industry pain point. According to Pure Global’s CTO, Ran Chen, after achieving clearance in one market, many MedTech firms still rebuild their entire regulatory file separately for every new country. “A submission for Mexico and another for Brazil felt like two completely separate projects,” Chen said. “AI Builder eliminates that redundant, time-consuming work.”
AI Builder’s output isn’t purely automated: it’s backed by Pure Global’s global team of regulatory experts, who maintain local templates and country-specific rule sets in nearly 20 offices worldwide. That human oversight ensures the platform’s drafts stay aligned with current guidance and compliance norms.
In early pilot use cases, the results were striking. Pure Global’s Brazil office applied AI Builder to 27 registration projects and cut the assembly time from 25–30 business days to just 5–8 days. The team reported fewer errors, faster internal reviews, and quicker readiness to submit.
Beyond time savings, Pure Global believes AI Builder can significantly reduce regulatory costs, enabling companies to scale into multiple geographies more affordably. The company argues that this could open the door to “10× more markets, 10× faster, and 10× more affordably” for its customers.
As regulatory frameworks around the world grow more complex, the need for scalable, AI-driven solutions is becoming more urgent. With AI Builder, Pure Global aims to reshape how medical device companies navigate that landscape — simplifying global expansion without compromising accuracy or compliance.
