PureFDA

About PureFDA

PureFDA, operating under the legal name PureID Medical Technology Co., Ltd. and also known as Pure Global, is a life sciences service provider that leverages artificial intelligence and data to assist medical technology companies with global market access. Founded in June 2020 by CEO Phyllis Meng and COO DJ Fang, the company originated as a volunteer effort to address the shortage of medical supplies during the COVID-19 pandemic.

The founders' backgrounds are integral to the company's strategy. Phyllis Meng, an alumna of Shanghai Jiao Tong University, has a technical background that includes roles as a key technical lead at Google and a quantitative researcher at Citadel Securities, with expertise in AI, algorithms, and biomedical engineering. DJ Fang holds dual degrees in Finance and Computer Science and a Master's in Information Security, bringing over a decade of experience in data science and software development. This blend of expertise in technology and finance underpins the firm's data-driven approach to regulatory compliance. The company was formally established after the founders recognized a significant gap in market access support for MedTech products, initially focusing on helping manufacturers navigate US regulations for pandemic-related items.

PureFDA's business model combines a SaaS and data service with comprehensive consulting. It serves a diverse clientele, from startups needing agile regulatory guidance to large multinational enterprises seeking to optimize their global portfolios. The company generates revenue by providing a suite of services for medical devices, in vitro diagnostics (IVDs), and medical software. These services include regulatory strategy, product classification, technical documentation, US FDA 510(k) submissions, CE marking, and quality system implementation. Pricing is market-oriented, with document writing services ranging from CNY 100,000 to 200,000 depending on product risk, and clinical trial projects potentially reaching into the millions.

The core of PureFDA's offering is its global regulatory intelligence platform, which utilizes big data and AI to provide access to information from over 100 countries, including data on 600,000 global wholesalers and 3 million medical device registrations. This platform supports services like real-time regulatory monitoring and AI-assisted technical document management to enhance efficiency and accuracy. The company also offers end-to-end clinical trial management and acts as a local representative in over 30 countries, with a physical presence through subsidiaries in North America, Europe, and Asia-Pacific. Having reached the Series B stage, PureFDA has secured over CNY 100 million in funding from investors including Legend Capital, Bayland Capital, Kangjun Capital, and Probe New Medical Fund.