This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.
Pure Global has introduced AI capabilities designed to simplify and accelerate regulatory tasks for medical device manufacturers. The tools go beyond basic data delivery by interpreting product details against market requirements, helping compliance teams focus on what needs to be done.
The launch introduces two capabilities: an AI-powered document builder and PureAnswers, a real-time platform for regulatory support. Both are designed to address the common bottlenecks teams face when working across multiple markets. While many companies already had access to regulatory data, they were still spending weeks piecing it together. Pure Global built these tools in response to that gap, giving teams direction and cutting down the time spent sorting through data. The launch reflects the company’s broader goal of reducing friction in global market access and making regulatory work more efficient and practical
“Over the years, we’ve built up a strong base of data and AI tools,” said Phyllis Meng, CEO & co-founder of Pure Global. “What we’ve learned is that clients don’t just want tools. They want clear answers. Whether they’re registering a product in Brazil or planning for the U.S. market, they need information they can act on right away.”
In reflection of that, the AI document builder pulls key information such as product specifications, safety language, and company details from user-provided materials to generate draft submission documents in minutes. What once required days of compiling and formatting can now be done in a single workflow, allowing more time for expert review and reducing repetitive manual work.
Similarly, PureAnswers gives MedTech teams direct support when they need direction on requirements. Instead of searching through databases or checking multiple sources, users can enter a question or device details and get a direct response. The Classification Checker compares the device against existing registrations, rules, and risk categories to suggest how it would likely be classified in the target country. Beyond classification, the tool supports product grouping and market research, helping teams understand how best to organize submissions and where their product sits in relation to competitors. It pulls from both Pure Global’s internal databases and public regulatory data, using large language models and fuzzy search to deliver specific, relevant results.
Looking ahead, Pure Global is continuing to build on this foundation. Upcoming updates will include deeper AI integration across expert reviews and client workflows, expanded compliance checklists covering more international standards, and new modules tailored to specific needs such as post-market surveillance, real-world evidence, and clinical planning. These additions reflect a broader move to embed AI across the full regulatory lifecycle, from early planning to submissions and post-market work.
