Pure Global’s Pure Global Resource Center is at the heart of our offerings, featuring an advanced suite of AI- and data-powered research tools designed to streamline the regulatory and clinical processes for medical device and IVD companies across more than 30 markets. These tools automate critical steps in the regulatory workflow, enabling you to accelerate your time to market. With the Resource Center, you can effortlessly access the latest global regulatory news, simplify document searches, compare clinical research data, and efficiently manage your registrations.

Our innovative tools include AI & Data Tools, Translation Automation in 25 languages, a Documentation Generator, Data Insights and Regulation Monitoring, a Clinical Research Database, a Global Distributor Database, and Certification Management. Additionally, we provide comprehensive Regulatory Support, Clinical Trial Support, In-Country Representation, Post Market Surveillance, and essential testing services such as Biocompatibility Testing, Packaging Testing & Sterilization Validation. Supported by our team of experts, many holding Regulatory Affairs Certification (RAC), and our extensive clinical experience across more than 15 locations worldwide, Pure Global transforms the way you approach regulatory compliance.

Pure Global assists with medical device registration in numerous markets, including Brazil (ANVISA), Argentina (ANMAT), Colombia (INVIMA), Bangladesh (DGDA), Australia (TGA), the US (FDA), Canada (CDMR), the EU (MDR/IVDR), the UK (MHRA), Switzerland (Swissmedic), Mexico (COFEPRIS), Peru (DIGEMID), Israel (AMAR), Egypt (EDA), Saudi Arabia (SFDA), UAE (MOHAP), China (NMPA), Singapore (HSA), India (CDSCO), Hong Kong (MDD), Indonesia (MOH), Taiwan (TFDA), Thailand (FDA), the Philippines (FDA), Japan (PMDA), Vietnam (MOH), and Pakistan (DRAP). Visit our Markets page for detailed assistance in each region.

Experience

• Joined APSense.com

  Dec 2024