PureFDA provides a SaaS+Data platform and end-to-end consulting for medical devices, IVDs, and medical software AI to support cross-border regulation, registration, testing, and overseas clinical trials. The company aggregates big-data and computer-technology experience to create a standardized, digital system that helps Chinese medical-device firms enter global markets. Its service network spans 10 countries and regions, and it operates eight branch companies with overseas clinical centers certified to standards such as CLIA, CAP, and ISO 17025. PureFDA says it has worked with over 100 Chinese and international medical and biotech companies. The firm plans to use new funding to build overseas medical-device resources, expand its professional talent team, strategically grow in the medical-devices field, and upgrade its big-data and global regulation intelligence platforms. Founded in June 2020, PureFDA positions itself as a one-stop, full-chain service ecosystem for cross-border medical-device commercialization.

Total raised

$14M

Funding rounds

1

Latest round

Series B

Latest activity

Nov 2022