Transforming Healthcare Compliance with AI: A Q&A with DJ Fang, COO of Pure Global

My background sits at the intersection of technology and regulated industries — I hold degrees in finance and information systems plus a master’s in information security, and I spent over a decade in data science, security, and software development across the finance and healthcare sectors before co-founding Pure Global. That mix shapes how I lead: I think about regulatory work as a data and engineering problem as much as a compliance one.

Pure Global is a global market-access partner for medical device and IVD

manufacturers. We started out in 2020 as a volunteer effort during the pandemic,

helping source critical medical supplies for U.S. schools and hospitals facing shortages. We quickly saw how badly manufacturers struggled to navigate regulatory approval, and turned that into a company. Today, our goal is to take that burden off device makers, whether they are a startup or a multinational. We help them register and stay compliant across more than 30 markets in Asia, Europe, and the Americas. To do this, we combine on-the-ground local representation with AI-assisted tools, all wrapped up in a transparent, flat annual fee.

In medical device regulation, trust isn’t a marketing claim — it’s the entire product.

We’re often the legal name on a manufacturer’s registration in a given country, which means clients are handing us responsibility for their ability to sell in that market. We earn that by being genuinely embedded where the work happens. We don’t rely on a loose network of subcontractors. Instead, Pure Global operates its own locally established offices across 15+ countries. That means the people advising a client on Brazil’s ANVISA or Singapore’s HSA actually live and work inside those systems.

Authority follows from consistency and transparency. We’ve delivered thousands of registration certificates for hundreds of clients, and we work hard to give the whole industry value before anyone signs with us. We gather and openly share as much regulatory data, intelligence, and practical resources as we can through our platform, from weekly regulatory news to our global databases of registrations and clinical trials. Pricing is flat and published openly on our website rather than buried in custom quotes. When you combine real local presence, a verifiable track record, generous sharing of knowledge, and transparency about how you work, trust compounds.

Solve a real, painful problem for real people before you fall in love with your solution. Pure Global didn’t begin as a polished business plan — it began with schools and hospitals that couldn’t get medical supplies during a crisis. We followed the pain, and the pain kept pointing us toward a deeper, more structural problem: the regulatory friction that keeps quality medical technology from reaching the markets that need it. The business model emerged from staying close to that problem, not from a whiteboard.

The flip side of that is staying close to your customer even as you scale. It’s tempting, once you have hundreds of clients and offices on five continents, to start optimizing for internal metrics and lose the texture of what people actually struggle with. We deliberately keep “Customer First” as a core value and structure the company so our regulatory experts are local and accessible, not abstracted behind layers. The founders who lose the thread usually lose it because they stopped listening once things were going well.

I’d also tell founders to treat patience and urgency as complementary, not opposing, forces. Regulatory market access is inherently long-cycle work — registrations can take months or years, and you can’t shortcut a health authority’s review. But within that, you should be relentlessly impatient about your own execution: response times, document quality, how fast you adopt better tools. Be patient with the parts you can’t control and intensely urgent about the parts you can.

Technology is the reason Pure Global can deliver our services at the speed and price point we do. Historically, regulatory market access has been a slow, opaque, and expensive process, requiring armies of consultants to manually reformat dossiers, navigate foreign-language regulations, and rebuild documents market by market. We have spent years transforming that manual effort into structured data and software. Today, our platform aggregates regulations from over 100 countries, 5 million registered products, 600,000 distributors, and a million clinical trial records. Research that once took weeks is now reduced to a simple search.

Today, AI handles the heavy lifting on the documentation side. In late 2025, we launched AI Builder to tackle a major industry pain point: the need to rebuild submission packages from scratch for every new market. Previously, expanding an FDA-cleared or CE-marked product into Mexico and Brazil felt like two entirely separate projects. AI Builder changes that by intelligently reusing existing regulatory files. It extracts key data from a home-market submission, runs an automated gap analysis against target country requirements (like ANVISA or COFEPRIS), generates drafts in minutes, and clearly flags missing information. It can even prepare multiple countries in parallel from a single source file. The results speak for themselves: in an early pilot, our Brazil team reduced document assembly time across 27 projects by 75%—dropping from 25–30 business days to just 5–8. Alongside this, our AI handles translation for 25 languages and continuously monitors global regulatory shifts to keep clients ahead of the curve.

That being said, we are very clear on one thing: AI augments our experts; it doesn’t replace them. Health authority submissions carry high stakes for both patient safety and a company’s commercial future, which is why a qualified regulatory professional always owns the final outcome. By letting technology handle the repetitive, low-judgment tasks—like searching, formatting, translating, and monitoring—our experts are freed up to focus on strategy and judgment. That unique combination of AI execution, elite human expertise, and genuine local presence is what truly sets Pure Global apart from traditional consultancies and standalone software tools.

The single biggest opportunity is regulatory convergence—countries cooperating with each other—and that pace has accelerated sharply over the past year. For example, Mexico’s COFEPRIS launched a fast-track equivalency, or “reliance,” pathway in September 2025. Now fully operational in 2026, it targets a roughly 30-business-day review for devices already cleared by a recognized reference authority like the FDA, Health Canada, or Japan’s PMDA. Even China’s NMPA, long regarded as one of the most self-contained systems in the world, is opening up. In July 2025, it launched a Malaysia–China medical device regulatory reliance pilot under the GHWP. This is its first reciprocal arrangement of this kind, and it sits alongside broader acceptance of foreign ILAC-accredited test reports and MDSAP audit evidence. As these reliance pathways mature, a manufacturer’s approval in one major market increasingly becomes a springboard into many others. Whoever can help clients strategically sequence those approvals to unlock the most markets for the least cost and effort will create enormous value, and that’s exactly where we’ve oriented the company.

The second opportunity is the long-overdue digitization of regulatory affairs. This is still a remarkably manual, paper-and-PDF industry. The combination of structured global regulatory data and modern AI makes it possible to compress timelines and costs by an order of magnitude, and frankly, most of the industry hasn’t begun that transition. There’s room to fundamentally re-architect how this work gets done, not just make it incrementally faster.

Finally, I see real opportunity in democratizing access for smaller innovators. Historically, only large manufacturers could afford to pursue global registration, which meant a lot of genuinely good technology from startups never reached patients outside its home market. Flat, transparent, technology-driven pricing changes that math. If a startup can realistically plan and budget to enter a dozen countries, more innovation reaches more patients worldwide — which is ultimately the mission underneath the business.

Start from the problem, not the technology. The fastest way to lose focus is to adopt AI because it’s expected of you, then go looking for somewhere to apply it. We did the reverse: we identified our most painful, repetitive, high-volume bottlenecks — document drafting, translation, regulatory research, change monitoring — and brought technology specifically to those. When the technology is anchored to a concrete pain point with a measurable outcome, it earns its place. When it isn’t, it becomes an expensive distraction that pulls your team’s attention away from customers.

Be clear about where technology should and shouldn’t own the outcome. In a regulated, high-stakes field, that line is everything. We let AI do the heavy lifting on execution, but a qualified human always owns anything that carries consequences for patient safety or a client’s market access. Drawing that boundary explicitly actually accelerates adoption. Your team trusts the tools instead of fearing them, and your customers trust that judgment hasn’t been outsourced to a model.

Lastly, protect your focus by adopting deliberately rather than reactively. The technology landscape changes weekly, and if you chase every new capability you’ll thrash your organization and never go deep on anything. We pick a small number of high-leverage bets, integrate them properly into how people actually work, and measure whether they move real metrics — speed, cost, quality — before expanding. Let your mission be the filter: technology that demonstrably advances it earns real investment, and everything else gets passed on, however impressive the demo. Stay curious about what’s new, but disciplined about what you adopt — that’s how you get the upside of new technology without letting it pull you off course.