PureCRO: A SaaS-Driven Medical Device CRO Empowering Chinese Healthcare Companies to Go Global

The COVID-19 pandemic has served as a catalyst reshaping the global medical device industry landscape. Coupled with the impact of centralized procurement and intense domestic competition, expanding overseas has become a critical breakthrough for many Chinese medical device companies to unlock their second growth curve.

However, pharmaceuticals and medical devices are special commodities subject to stringent regulatory controls and market access requirements. To become a globalized healthcare enterprise, it is essential to understand the target market’s healthcare landscape, regulatory policies, as well as public sentiment and environmental trends.

Regulatory requirements across overseas markets are not mutually recognized, with different countries having distinct regulatory authorities for medical products. Information asymmetry and mismatches in overseas clinical resources have prevented many Chinese companies from entering multi-country markets.

Identifying the appropriate regulatory authorities and understanding the target country’s official regulatory philosophy for different products is the first step in entering that market. Consequently, demand is growing for cross-border regulatory CROs that offer multi-country, multi-category, one-stop services and possess overseas clinical resources.

However, the quality of overseas medical device CRO services varies significantly, with a lack of service integration and industry standards, leading to numerous irregularities that hinder the global expansion of medical device companies—

• In the Clinical Stage, currently, the clinical resources of most traditional medical device CROs are deployed in China, and their support for overseas device market entry is limited to device registration and quality system management, failing to provide companies with necessary overseas clinical trial resources;

• During the registration phase,Certification standards vary significantly across countries and product categories. Traditional medical device CROs are small and fragmented, offering certification services for only a single country or specific medical device category, and are highly dependent on technical talent and expertise. They fail to meet enterprises’ needs in niche markets.

• In the post-marketing phase,Traditional medical device CRO services cease upon product launch, lacking support for post-market renewal management, market research, and sales enablement, thereby failing to meet enterprises’ ongoing needs for entering overseas markets.

Leveraging a SaaS+Data-driven intelligent overseas medical device CRO platform, PureCert Medical Technology (Guangzhou) Co., Ltd. (hereinafter referred to as “PureCert”) has targeted this blue-ocean market. By leveraging data capabilities and global organizational expertise, PureCert has entered the healthcare sector, significantly enhancing the efficiency of clinical trials and regulatory approvals for medical devices and in vitro diagnostics (IVD) products.

At the beginning of the Year of the Tiger, PureDx secured tens of millions of yuan in Series A financing, with participation from Kangjun Capital and the Probe New Healthcare Fund. Recently, VCBeat interviewed Meng Zhu, founder of PureDx, to help medical device companies planning to expand overseas gain a better understanding of the company.

Founded in June 2020, PureReg is a one-stop service provider for Internet-plus global medical device regulatory compliance qualifications in China, and a globally leading SaaS+Data-based intelligent overseas medical device CRO platform.

Its core business is to assist medical device companies with export certifications (FDA, CE, UKCA, TGA, etc.), multi-country regulatory consulting (excluding domestic NMPA), quality system guidance (ISO 13485, QSR 820, etc.), overseas clinical trials (Europe and the US), global healthcare big data services (distributor data, clinical data, etc.), and AI system services and support for medical devices.

Unlike traditional CROs, this emerging company is more akin to a CRO specializing in industrial information integration.

Leveraging extensive data accumulation, artificial intelligence technologies, and the innovative empowerment of next-generation information technology, PureCert has independently developed and establishedGlobal Regulatory Intelligence Platform (GRIP)(Global Regulatory Intelligence Platform) — An integrated entity that seamlessly combines technology, regulations, and data.

PureReg has independently developed and established a global regulatory intelligence platform. Image provided by the company.

The Global Regulatory Intelligence Platform offers features such as Certification Path, Intelligence Monitor, Compliance Data, and Testing Advice to facilitate market access for medical devices. It covers regulatory requirements in over 30 countries and includes information on more than 200,000 global distributors, over 200,000 clinical records, and more than 3 million global medical device registrations.and can be personalized according to the enterprise's situation,Implement Intelligent Solution Matching, providing data services such as product trade analysis, overseas distributor networks, and clinical trend research to comprehensively and robustly support enterprises in launching their products globally.

Meanwhile, the platform possessesMulti-country Registration System, Overseas Clinical System, Global Data System,and the corresponding data support for these three sectors—Trade DataProvide Trade Data Analysis, providing recommendations for customer market decisions;Distributor InformationProvide information on overseas distributors,Facilitating Overseas Market Expansion;Clinical DataProviding overseas clinical laboratory resources and global trends in clinical research.

Clinical Data Example, Image Provided by the Enterprise

Providing a tripartite service to our extensive user baseMarket access in 30+ countries, 200,000+ global distributors, 200,000+ clinical records, and 3 million+ global medical device registrationsand other information. and can be personalized according to the enterprise's situationIntelligent Solution Matching, providing comprehensive support for enterprises to ensure their products comply with international regulations when expanding overseas.

Meng Zhu stated, “I hope PureCert will not merely be a simple intermediary agency, but a global enterprise capable of empowering the medical innovation sector. Our vision is to leverage our industry expertise in computer technology and big data to empower medical innovation through next-generation technologies. By utilizing information technology, we aim to establish a formalized and standardized system for the international expansion of medical devices, covering the entire process—including overseas market access, international clinical trials, SaaS platforms, and data platforms—through technological solutions.”

In 2020, the COVID-19 pandemic swept across the globe. At that time, Meng Zhu, who was still working on Wall Street, learned of the shortage of medical supplies in China and took the initiative to procure such supplies for the country. Later, as the epidemic situation in China stabilized while outbreaks surged in the United States, Meng Zhu sought to donate some of China’s medical resources to the U.S.

During this process, she encountered numerous challenges: “Standards for supplies such as face masks and protective suits vary across countries. It is no easy feat for medical products manufactured in China to cross borders, meet diverse regulatory requirements, and enter the global market in a compliant and expedient manner.”

“A gust of wind begins as a mere ripple on the duckweed.” In this process, Meng Zhu keenly observed, “For Chinese medical enterprises, this epidemic has been both a challenge and an opportunity. I hoped to contribute my share to this tidal wave, so I resigned from my position and returned to China to found Purui.” When discussing her original motivation for starting the business, Meng Zhu’s gentle, soft-spoken voice carried a hint of resolve.

PureCertCEO Meng Zhu

Meng Zhu, Founder and CEOMs.With an educational background from prestigious institutions both in China and abroad, Ms. Meng Zhu holds a Bachelor’s degree in Biomedical Engineering from Shanghai Jiao Tong University and a Master’s degree in Computer Science from Carnegie Mellon University in the United States, providing her with an interdisciplinary expertise at the intersection of healthcare and information technology. Prior to returning to China to found PureCert, she held key positions at Google and Citadel Securities, the world’s largest market maker, where she accumulated over a decade of in-depth experience in big data and artificial intelligence.

The PureCert team is composed of multidisciplinary experts, including senior advisors to multiple Fortune 500 companies, authorized signatories for international and domestic medical standards committees, and R&D executives at publicly listed groups. All core members possess decades of extensive experience in technology consulting, product development, medical certification, and global medical registration.Over 50% of the company's team members are returnees.The talent pool includes graduates from prestigious overseas universities such as Columbia University and Johns Hopkins University.

under its umbrellaPuri Medical Technology Research InstituteOur expert team comprises a distinguished group of professionals, including pioneers from the first generation of the global medical device certification industry, experts with over 30 years of experience in medical device certification, a Ph.D. in Molecular Pathology from the United States, a cellular and molecular biology specialist from Yale University, a former auditor for European CE Notified Bodies, industry experts from top-ten U.S. medical device companies, a director of a U.S. national diagnostic laboratory, a head of medical regulations at a leading U.S. biotechnology company, renowned frontline physicians from various countries, and several holders of the Regulatory Affairs Certification (RAC) for international medical devices.

In addition, PureCert boasts a global network of regulatory and clinical experts. Its native English-speaking chief expert team provides comprehensive support for the preparation of clients’ technical documentation. The team also includes China-based postdoctoral fellows in clinical medicine and academic specialists in immunology and cell biology, who are available to deliver localized technical support for clients’ IVD products. This truly enables domestic manufacturers to achieve European-standard technical documentation while benefiting from localized communication and service support in China.

Meanwhile, Pure’s international team possesses in-depth knowledge of regulatory policies across European countries, leveraging professional expertise and best-in-class responsiveness to help clients identify optimal solutions and enter overseas markets with maximum speed.

Leveraging the global perspective, technical resources, and clinical capabilities of its international team, PureDiag has servedOver 100 medical device companies, including Hotgen Biotech, Mingde Biology, Orient Gene, BGI Genomics, InnoCare Diagnostics, and Zhongyuan Huiji.

PureCert is dedicated to providing professional one-stop consulting services to global healthcare enterprises. Its areas of expertise and service scope are continuously expanding to maintain a competitive edge in the increasingly complex global market, thereby delivering comprehensive solutions to a broader clientele.

PureDiagnostics’ service network spans nine countries and regions worldwide, including the United States, Germany, Italy, Spain, Switzerland, and Poland, with eight major subsidiaries and 13 branch offices. Its overseas clinical centers in Europe and the United States hold accreditations such as CLIA, CAP, and ISO 17025, and possess scarce clinical resources within the industry.

Pure Clinical, the European CRO under Pure Certification, operates seven high-quality, compliant clinical laboratories across Europe and North America, providing clients with exclusive IVDR clinical trials. Furthermore, Pure Certification has established Undergraduate Research Programs (URP) in collaboration with institutions such as Johns Hopkins University and the University of Chicago to help students gain insights into the industry and relevant regulations. In the future, Pure Certification will expand its collaborations with an increasing number of Chinese universities.

While expanding its global footprint, PureCert has also been strengthening its core competencies. To date, the company has successfully secured four software copyrights, including those for the PureCert Compliance Query Big Data Platform and the PureCert Intelligent Chatbot Control Software. It has filed two invention patent applications, which have entered the substantive examination phase. Meanwhile, six additional invention patent applications and software copyrights are currently in preparation.

PureCert Software Copyright Registration Certificate, image provided by the enterprise

Regarding the future of PureCert, Meng Zhu has a clear roadmap: the company will continue to focus on SaaS+Data-driven CRO services for medical devices, building a one-stop, full-chain service ecosystem. Within the next year, it aims to provide market access services in 20 countries for Chinese medical device companies, expand its global pool of certified experts in medical device regulations, and establish overseas clinical centers to drive global expansion. Within three years, it plans to offer regulatory compliance consulting services covering 50 countries worldwide, build an internet platform for the medical device industry, and prepare for an initial public offering (IPO).

Progress in the industry sometimes stems from cross-disciplinary technological innovations. By breaking free from existing constraints and adopting a third-party perspective, one can more objectively uncover underlying logic. We look forward to PureDiagnosis transforming the current R&D paradigms for medical devices and IVD, empowering Chinese healthcare companies and products to go global, and bringing greater Chinese representation to the world stage of healthcare.