about us

Our mission: we provide next generation solutions for MedTech companies to expand their global reach.

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.


We Work
With Honesty

Trust is the cornerstone of our relationships with customers, employees, and partners. We uphold the highest ethical standards, fostering an environment of transparency and accountability. Even in challenging times, we remain steadfast in doing what is right.


We Strive
For Quality

Passion fuels our pursuit of excellence. We maintain unwavering dedication to our craft, continuously seeking innovative approaches to exceed industry standards. Settling for anything less than exceptional is simply not an option.


We Collaborate

Collaboration lies at the heart of our success. We embrace a culture of continuous learning, leveraging each other's strengths to drive collective growth. By fostering a supportive and inclusive environment, we cultivate a sense of belonging where everyone thrives.

Customer First

We Prioritize
Customer Needs

We prioritize understanding our customers' true needs and consistently strive to surpass their expectations. Placing the customer at the heart of our operations ensures we deliver solutions that resonate and inspire confidence.


We Lead With

Empowered by our belief in making a meaningful impact, we approach every challenge with determination and resilience. Our proactive mindset propels us to push boundaries and pioneer change, confident in our ability to achieve remarkable outcomes.


Meet our Founders

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.

Founder, CEO

Phyllis Meng​

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.

Co-Founder, COO

DJ Fang​

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.

founding story

How Pure Global
came about

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 Journey

Our Journey and Milestones

Key milestones in the company's history, highlighting major achievements, expansions, and innovations.


Official Launch of Pure Global's Regulatory Intelligence Platform
Market Access - Brazil
Market Access - Colombia
Market Access - Indonesia
Market Access - Japan
Market Access - Singapore
Market Access - Malaysia
IVV Labs in Sweden joins Pure Global
PureFDA rebranded as Pure Global
Pure Global's Regulatory Intelligence Platform successfully passed Microsoft's compliance audit and landed in the Azure Global Marketplace


Series A financing completed
50+ CE certificates at the end of the IVDD era, covering a large range of products
Our Guangzhou headquarters moved to Guangzhou International Bio-Island.
Series B financing completed
We were awarded the official BSI ISO 13485 certificate.
Pure Standard Lab Corp. US established


First round angel financing completed.
Our second China office was officially opened
Pure Clinical Poland established
Market Access - European Union
Market Access - Australia
Market Access - United Kingdom


Market Access - United States
Our first China office was officially opened
Our United States office was officially opened
Market Access - China
Our Awards

Industry Awards & Recognitions

Our team members have been recognized for their excellence in the industry.

Northeast Regionals 2024: Fastest Growing Companies
Top 100 Outstanding Overseas Returnees – Phyllis Meng
2023 FORBES China
Top 30 China Globalization Youth
Most Socially Influential Start-up Company
2022 Fortune China
Our certificates

We meet the highest standards

With ISO 13485 certification and a team of RAC-certified professionals, we maintain the highest standards in the medical device industry.


We are Deeply Involved in Social Responsibility Projects

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.

Contact us
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Anywhere You Are.

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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