Agency Overview
Pure Global is a medical device regulatory consulting company that leverages AI, Big Data, and software to streamline registration and clinical projects for medical device and IVD companies across more than 30 markets. With our team of experts, many of whom hold Regulatory Affairs Certification (RAC), and our Pure Global Resource Center, we are revolutionizing how our clients achieve and maintain market access in a rigorous global regulatory landscape.
No. of Employees
50+
Services Overview
Backed by our consulting team, extensive clinical experience, and more than 15 locations worldwide, Pure Global will change the way you approach regulatory compliance. We offer a wide range of services, including:
● AI & Data Tools
○ Translation Automation in 25 languages
○ Documentation Generator
○ Data Insights and Regulation Monitoring
○ Clinical Research Database
○ Global Distributor Database
○ Certification Management
● Regulatory Support
● Clinical Trial Support
● In-Country Representation
● Post Market Surveillance
● Biocompatibility Testing, Packaging Testing & Sterilization validation
Languages
English
Technical Proficiency
Bringing new medical products to the market can be challenging but it doesn’t have to be. Our Pure Global Resource Center is a suite of AI- and data- powered research tools that automate steps in the regulatory process, so you can get to market faster. Easily access breaking global regulatory news, streamline document searches, compare clinical research data, and manage your registrations.
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