For medical device companies, navigating global regulatory pathways has long been one of the most time-consuming and complex hurdles to market access. Now, Pure Global — a regulatory tech firm— is betting on AI to change that.
This week, the company announced the launch of two new AI-powered tools designed to streamline compliance tasks that previously took regulatory teams days or even weeks to complete. The tools will be officially unveiled at RAPS Euro Convergence 2025 in Brussels and Hospitalar in São Paulo later this month.
At the core of the rollout are two products: an AI-powered document builder and PureAnswers, a real-time platform offering regulatory support and classification analysis. Together, they aim to accelerate the submission process by generating compliant documents and providing market-specific guidance based on product data and device profiles.
“What we’ve learned is that clients don’t just want tools — they want clear answers,” said Phyllis Meng, CEO and co-founder of Pure Global. “Whether they’re registering a product in Brazil or preparing for the U.S. FDA, they need direction they can act on — fast.”
The company says the AI document builder pulls key information — such as product specifications, labeling, and safety claims — from existing materials and converts it into draft regulatory submissions. What once required days of manual formatting and data input can now be done in minutes.
Meanwhile, PureAnswers functions as an interactive regulatory advisor. Users can input device details or submit questions, and the platform returns targeted responses, from classification suggestions to documentation requirements and market entry strategies. It leverages a combination of Pure Global’s proprietary data and public regulatory databases, enhanced by large language models and fuzzy search algorithms.
While there’s no shortage of regulatory databases on the market, many companies still face the same challenge: translating data into decisions. According to Pure Global, these tools fill that gap by transforming static information into workflow-ready outputs — helping MedTech teams prioritize next steps and reduce time to market.
The company is also planning to expand its platform capabilities later this year. Future updates will include AI-driven expert review modules, expanded international compliance checklists, and features for post-market surveillance and real-world evidence planning.
With global regulations growing more complex — and timelines for market approval tightening — Pure Global’s approach reflects a larger trend in the healthcare and MedTech sectors: the shift from manual compliance work to automated, AI-enhanced regulatory intelligence.
If the tools live up to their promise, Pure Global may not just be making submissions faster — it could be redefining how regulatory strategy is executed from day one.
