Pure Global is a medical device regulatory consulting company, certified under the BSI ISO13485:2016 quality management system. Our skilled team holds Regulatory Affairs Certification (RAC) and brings extensive knowledge and international expertise to assist clients with global expansion. As leaders in regulatory affairs for medical devices and in-vitro diagnostics, our globally dispersed consultants, all certified and clinically experienced, emphasize our commitment to expert guidance in a complex regulatory environment.
We provide a broad spectrum of services to support the introduction of new products into the market, including regulatory support, clinical trial assistance, in-country representation, post-market surveillance, and testing for biocompatibility, packaging, and sterilization. Utilizing advanced AI and data tools, we offer market intelligence, up-to-date regulatory news, clinical research databases, and access to a global distributor network. Our certification management ensures streamlined processes and compliance.
Our global representation and registration services encompass a wide range of regions and countries, ensuring compliance with local regulations. We handle medical device registrations for various markets, including the United States (FDA), United Kingdom (MHRA), European Union (CE Marking), Canada (CMDR), China (NMPA), Japan (PMDA), Brazil (ANVISA), and more. Each country-specific service is tailored to meet the strictest regulatory standards and facilitate market entry.
Located in Jersey City, New Jersey, Pure Global is dedicated to navigating the intricacies of international medical device regulations, offering strategic insights and solutions that allow clients to successfully market their products worldwide. Our goal is to be your trusted partner in achieving global regulatory compliance and market success.
