Pure Global has launched AI Builder, a new platform designed to simplify and accelerate the process of registering medical devices in 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 to cut 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 (pictured), 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.
Customisation 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.
The change helped projects to move faster and gave experts more time to focus on meaningful, strategic work.
“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.”