We are a leading trusted global growth partner to MedTech companies delivering smart and efficient market access solutions powered by transformative data & technology, high quality domain expertise.
The founders team combines decades of experience in international business, medical device registration, clinical research, and entrepreneurship. With strong backgrounds cultivated from their tenure at top-tier tech companies, they bring invaluable insights to the development of our AI technologies. Their achievements include pivotal roles at leading institutions and successful entrepreneurial ventures.
A former key data expert at Citadel Securities and technical team leader at Google, she blends artificial intelligence with biomedical engineering, holding several patents and accolades for her contributions to the field and entrepreneurship, particularly in IVD equipment development.
With dual degrees in Finance and Computer Science and a Master's in Information Security, and over a decade of expertise in data science, information security, and software development, contributing significantly to software and big data projects across finance and healthcare sectors.
During the early stages of the COVID-19 pandemic, our co-Founders DJ and Phyllis recognized a lack of companies helping Chinese medical device manufacturers gain market access in the United States for their COVID test kits.
As inquiries increased about getting these products certified, they realized the need expanded beyond COVID products - the whole industry needed more regulatory and market access support.
Thus, three years ago they founded Pure Global to assist not only Chinese manufacturers, but medical device makers globally to enter new markets.
Initially assisting with sourcing medical devices for schools and hospitals facing shortages, Pure Global formally incorporated to provide ongoing services bridging regulatory gaps between manufacturers and markets like the US and EU.
Now, our locally-established subsidiaries enable us to offer coordinated assistance across multiple geographies and needs.
Our team members have been recognized for their excellence in the industry.
With ISO 13485 certification and a team of RAC-certified professionals, we maintain the highest standards in the medical device industry.
Pure Global's CSR initiatives provide crucial support to NYC schools by donating COVID-19 resources. These contributions have been warmly acknowledged by children, reflecting the positive impact.
We support environmental and community initiatives.
We ensure ethical treatment of employees.
We contribute to community and economic development.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.