PureFDA completed an over CNY100M Series B financing to support its expansion and platform upgrades. The company will use the funds to build overseas medical device resources, expand its professional talent team, strategically grow in the medical devices field, and upgrade and iterate its big data information platform. Founded in June 2020 by MENG Zhu, PureFDA is a Hong Kong‑based SaaS + Data service provider focused on whole-process informatization for medical devices going overseas. It provides whole-process consulting services for compliance access to global markets for products including medical devices, in vitro diagnostics and medical software AI, covering regulatory consultation, local authorized representatives, product certification and registration, overseas clinical trials, technical documentation and system guidance, and product testing. PureFDA’s service network spans 10 countries and regions—including the United States, Germany, Italy, Spain, Switzerland and Poland—and the company operates eight branch companies. Its overseas clinical centers in Europe and the United States hold certifications such as CLIA, CAP and ISO 17025, and the company reports possessing scarce clinical resources in the industry.

Total raised

$14M

Funding rounds

1

Latest round

Series B

Latest activity

Nov 2022