PureFDA, a China-based SaaS+Data new digital cross-border medical device CRO company, announced that it completed over CNY100 million in Series B funding.
The round was led by Legend Capital, followed by the existing shareholder Bayland Capital.
The funds will mainly be used for the construction of overseas medical device resources, expanding the professional talent team, strategic expansion of the medical devices field, and upgrading and iteration of the big data information platform.
Regarding this financing, Meng Zhu, the founder of PureFDA, said, “Our original intention is to help Chinese medical device enterprises go overseas and expand overseas clinical resources. With 10 major clinical centers, we are committed to creating a one-stop and full-chain service ecosystem. Through the accumulation of experience in the field of computer technology and big data, we empower medical innovation by using the new generation of information technology to establish a standardized and digital system for medical devices going overseas. With the professional consulting service for multinational medical device market access and high-quality overseas clinical resources, PureFDA is capable of meeting the needs of Chinese medical device enterprises for cross-border registration of CROs in multiple countries and categories. PureFDA’s development is inseparable from the strong support of new and existing shareholders and customer partners. With the fresh proceeds, we will continue to upgrade the global regulation intelligence platform and help medical device enterprises license-out their products by providing data services such as trade analysis, overseas dealer network and clinical trend research.”
PureFDA provides one-stop solutions such as whole-process consulting services for compliance access to the global market and overseas clinical trials. The company’s service network has spread to 10 countries and regions worldwide, including the United States, Germany, Italy, Spain, Switzerland, and Poland.
PureFDA has eight branch companies and possesses scarce clinical resources in the industry. Its overseas clinical centers in Europe and the United States have been certified with qualifications such as CLIA, CAP, and ISO 17025.
Company: PureFDA Medical Technology (Guangzhou) Co., LTD.
Round: Series B
Funding Month: November 2022
Lead Investors: Legend Capital
Additional Investors: Bayland Capital
Company Website: https://www.purefda.cn/
Software Category: SaaS + Data Life Science
About the Company: Founded in June 2020, PureFDA is a global-leading SaaS + Data life science service provider focusing on whole-process informatization of medical devices going overseas in the global market. The company is dedicated to providing whole-process consulting services for compliance access to the worldwide market for products such as medical devices, in vitro diagnostics, and medical software AI, covering device regulation consultation, locally authorized representatives, product certification and registration, overseas clinical trials, technical documentation and system guidance, product testing, etc. have been doing business with over 100 Chinese and international medical and biotech companies and has been widely recognized by industry insiders.