Pure Global's AI Builder Cuts MedTech Regulatory Submission Time from Weeks to Days

New AI platform cuts documentation time by up to 75%, enabling MedTech companies to access 10x more markets, 10x faster, and 10x more affordably.

JERSEY CITY, N.J., Nov. 6, 2025 /PRNewswire/ -- Pure Global has announced the launch of AI Builder, a new platform designed to simplify and accelerate the process of registering medical devices across international markets. Built on deep expertise in global regulatory submissions, AI Builder tackles the inefficiencies, high costs, and delays that slow medical device registration by automating documentation and intelligently reusing existing regulatory files, cutting preparation time from weeks to days.

The idea originated from a persistent challenge observed across clients: after obtaining FDA clearance or CE marking, manufacturers often had to rebuild entire submission packages from scratch for each new market. "A submission for Mexico and another for Brazil felt like two completely separate projects," said Ran Chen, CTO of Pure Global. "We didn't set out to build another tool for companies to buy. We set out to solve the fundamental problem of redundant, time-consuming work in global registration."

AI Builder addresses that challenge through five core capabilities:

• Intelligent Data Extraction - automatically pulls key information from home-market submissions.
• Automated Gap Analysis - compares content against target-country requirements such as ANVISA or COFEPRIS.
• Rapid Document Generation - produces draft submission files for new markets within minutes.
• Missing Information Highlighting - flags incomplete sections, so teams know exactly what to address.
• Simultaneous Multi-Country Processing - enables parallel preparation for multiple markets from one source file.

Customization is inherent to the process. The platform is designed to ingest any set of source documents a client provides and tailor the output to the specific requirements of any target country in our network. Each project is, by definition, a custom-tailored output for that specific device and market.

The platform's strength lies in the blend of AI automation and human expertise. Pure Global's network of local regulatory specialists, spanning nearly 20 offices worldwide, continuously refines country-specific templates and rule sets. This ensures each draft remains aligned with the latest requirements while maintaining the company's high standards for accuracy, data security, and confidentiality.

Early adoption results have been significant. In a recent pilot, Pure Global's Brazil team cut document assembly time for 27 projects from 25–30 business days down to 5–8 days; roughly a 75% reduction. The change helped projects move faster and gave experts more time to focus on meaningful, strategic work.

In addition to its automation capabilities, AI Builder enables Pure Global to offer a disruptive new pricing structure. Clients can now access an all-inclusive annual fee, covering the complete registration process for each device. This package includes compilation of registrations with required translations, submission to local authorities, generation of import authorizations for distributors/importers (if applicable), filing of post-approval modifications and renewals, and post-market surveillance correspondence, simplifying budgeting and providing full transparency.

Unlike traditional regulatory intelligence platforms, AI Builder is not a standalone software product. It powers Pure Global's own registration services, enabling faster and more affordable delivery. "Other tools give you the rules," Chen added. "We give you the result, submission files ready to move forward."

AI Builder is currently deployed across Brazil and will expand next to Mexico and Southeast Asia. Future updates will deepen automation, expand regional coverage, and move closer to Pure Global's long-term vision: an ideal, "Amazon-like" experience for global medical device registration, where manufacturers can upload existing documentation and instantly generate drafts for multiple markets.

"With AI Builder, we're making global market access practical, transparent, and on-demand," Chen said. "It's the foundation of our AI-native approach, reducing friction so our clients can reach more patients, in more countries, faster than ever before."

For more information, contact:
Alma Miftari at [email protected] or +38 148110906

About Pure Global

Pure Global specializes in delivering next-generation solutions tailored to MedTech firms aiming to expand their global reach. Its comprehensive approach aids clients in making informed decisions, refining market entry strategies, and addressing the complexities of global standards through expert guidance from local market specialists.

SOURCE Pure Global