Pure Global is a medical device regulatory consulting company, certified under the BSI ISO13485:2016 quality management system. We specialize in helping our clients navigate the complex landscape of global regulatory requirements for medical devices and in-vitro diagnostics. Our team comprises experts who hold Regulatory Affairs Certification (RAC) and have significant clinical and regulatory experience.

Our services are designed to support the introduction of medical devices to international markets, ensuring compliance with applicable regulations. We provide a full spectrum of services that include regulatory support, clinical trial management, in-country representation, and post-market surveillance. Additionally, we conduct biocompatibility testing, packaging testing, and sterilization validation to meet safety and quality standards.

Leveraging advanced technology, we offer AI and data tools that enhance our services. These include market intelligence, the latest regulatory updates, a clinical research database, a global distributor database, and streamlined certification management. These tools enable our clients to make informed decisions and maintain compliance with regulatory bodies worldwide.

We assist with medical device registration in various countries, ensuring that our clients can achieve market access globally. Our registration services cover key markets such as the United States (FDA), United Kingdom (MHRA), European Union (CE Mark), Canada (CMDR), China (NMPA), Japan (PMDA), Brazil (ANVISA), and many others, accommodating the specific regulatory requirements of each region.

Our headquarters are located in Jersey City, New Jersey, from where we coordinate our global operations. With a commitment to regulatory excellence and client success, Pure Global stands as a leading consultant in the medical device regulatory field, dedicated to enabling the smooth introduction of medical devices into markets around the world.

Pure Global

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