Recently, PureFDA Medical Technology (Guangzhou) Co., LTD. (hereinafter referred to as “PureFDA”) announced the completion of the Series B round of financing of over CNY100 million, which was led by Legend Capital and followed by the existing shareholder Bayland Capital. This round of funds will mainly be used for the construction of overseas medical device resources, the expansion of the professional talent team, the strategic expansion of the medical devices field, and the upgrading and iteration of the big data information platform.
Founded in June 2020, PureFDA is a global-leading SaaS + Data service life science service provider that focuses on whole-process informatization of medical devices going overseas in the global market. Besides, the company is dedicated to providing whole-process consulting services for compliance access to the global market for products such as medical devices, in vitro diagnostics and medical software AI, covering device regulations consultation, local authorized representatives, product certification and registration, overseas clinical trials, technical documentation and system guidance, product testing, etc.
Relying on its top-notch expert team with regulatory certification and extensive clinical experience, 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. Moreover, it has been doing business with over 100 Chinese and international medical and biotech companies and has been widely recognized by industry insiders. PureFDA has 8 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.
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.”
Joe ZHOU, managing director of Legend Capital, said: “Going overseas has become a consensus in the development of China’s medical device enterprises, but it also faces a series of difficulties and challenges, of which the sore points are mainly concentrated in the access and marketing to the overseas market. With the increasing tightening of global device regulations, it is difficult, costly, long cycle, low efficiency and low success rate for enterprises to independently complete overseas access, leading a great need for the assistance of CRO service providers who focus on going overseas. However, the traditional expert CRO services are difficult to meet the diversified demands of the highly dispersed downstream device enterprises for their products to go overseas, and the scale effect and profitability of CRO enterprises also encounter bottlenecks. With its rich overseas clinical resources and new digital CRO services driven by data and algorithms, PureFDA has successfully achieved cross-country, cross-department and cross-category CRO capabilities, as well as significant advantages in cost reduction and efficiency enhancement. PureFDA is a company expected to break the bottleneck of traditional device CRO enterprises and bring disruptive changes in the equipment CRO industry.”
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