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 technical lead at Google and a quantitative researcher at Citadel Securities, has a proven track record of developing innovative solutions in data-intensive environments. Her expertise in AI, algorithms, and biomedical engineering has been instrumental in building and leading high-performing, technology-driven companies.
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.
Launched in 2020 by Phyllis and DJ, Pure Global began as a volunteer effort to address the critical shortage of COVID-relevant MedTech products (PPE, test kits, etc.) during the early stages of the pandemic. Recognizing a significant gap in market access support for these essential items, the founders quickly transitioned Pure Global into a formal company. From its inception, Pure Global has focused on developing technology to streamline regulatory market access and compliance for medical devices.
Initially concentrated on helping global manufacturers navigate US regulations for COVID-related products, they soon recognized the broader MedTech industry faced similar challenges. As demand for certification services increased, Pure Global expanded its mission to bridge regulatory gaps between manufacturers and key global markets.
Starting with sourcing medical devices for US schools and hospitals experiencing shortages, the company now has locally established subsidiaries, enabling coordinated assistance across multiple geographies and for a wide range of medical device 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.
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